Methods, systems and devices for cardiac valve repair

ABSTRACT

Disclosed are devices and methods for treating regurgitation through a valve in the heart. The devices can include an expandable, fluid-tight bladder configured to be deployed between valve leaflets of the heart valve. The bladder can include an upper portion that extends into the atrium of the heart; a lower portion that extends into the ventricle of the heart; and a middle portion positionable within the line of valve leaflet coaptation that provides a sealing surface for one or more of the leaflets.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/689,958 filed Jan. 19, 2010, which claims the benefit of priorityunder 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No.61/242,506, filed Sep. 15, 2009. Priority of the aforementioned filingdates is hereby claimed, and the subject matter of the above-notedapplications is hereby incorporated by reference in their entirety byreference thereto.

BACKGROUND

The present invention relates generally to medical methods, devices, andsystems. In particular, the present invention relates to methods,devices, and systems for the endovascular or minimally invasive surgicalrepair of the atrioventricular valves of the heart, particularly themitral valve.

Mitral valve regurgitation is characterized by retrograde flow duringsystole from the left ventricle of a heart through an incompetent mitralvalve into the left atrium. During a normal cycle of heart contraction(systole), the mitral valve acts as a check valve to prevent flow ofoxygenated blood back into the left atrium. In this way, the oxygenatedblood is pumped into the aorta through the aortic valve. Regurgitationof the valve can significantly decrease the pumping efficiency of theheart, placing the patient at risk of severe, progressive heart failure.

Mitral valve regurgitation can result from a number of differentmechanical defects in the mitral valve. The valve leaflets, the valvechordae which connect the leaflets to the papillary muscles, or thepapillary muscles themselves may be damaged or otherwise dysfunctional.Commonly, the valve annulus may be damaged, dilated, or weakenedlimiting the ability of the mitral valve to close adequately against thehigh pressures of the left ventricle. In some cases the mitral valveleaflets detach from the chordae tendinae, the structure that tethersthem to the ventricular wall so that they are positioned to coapt orclose against the other valve leaflet during systole. In this case, theleaflet “flails” or billows into the left atrium during systole insteadof coapting or sealing against the neighboring leaflet allowing bloodfrom the ventricle to surge into the left atrium during systole. Inaddition, mitral valve disease can include functional mitral valvedisease which is usually characterized by the failure of the mitralvalve leaflets to coapt due to an enlarged ventricle, or otherimpediment to the leaflets rising up far enough toward each other toclose the gap or seal against each other during systole.

The most common treatments for mitral valve regurgitation rely on valvereplacement or strengthening of the valve annulus by implanting amechanical support ring or other structure. The latter is generallyreferred to as valve annuloplasty. A recent technique for mitral valverepair which relies on suturing adjacent segments of the opposed valveleaflets together is referred to as the “bow-tie” or “edge-to-edge”technique. While all these techniques can be very effective, theyusually rely on open heart surgery where the patient's chest is opened,typically via a sternotomy, and the patient placed on cardiopulmonarybypass. The need to both open the chest and place the patient on bypassis traumatic and has associated morbidity.

SUMMARY

For the foregoing reasons, it would be desirable to provide alternativeand additional methods, devices, and systems for performing the repairof mitral and other cardiac valves, including the tricuspid valve, whichis the other atrioventricular valve. In some embodiments of the presentinvention, methods and devices may be deployed directly into the heartchambers via a trans-thoracic approach, utilizing a small incision inthe chest wall, or the placement of a cannula or a port. In otherembodiments, such methods, devices, and systems may not require openchest access and be capable of being performed endovascularly, i.e.,using devices which are advanced to the heart from a point in thepatient's vasculature remote from the heart. In other embodiments, themethods, devices, and systems should not require that the heart bebypassed, although the methods, devices, and systems should be usefulwith patients who are bypassed and/or whose heart may be temporarilystopped by drugs or other techniques. At least some of these objectiveswill be met by the inventions described hereinbelow.

In one aspect, there is disclosed a device for treating regurgitationthrough a valve in a heart, the heart having an atrium fluidicallycoupled to a ventricle by the valve, the valve including at least twoleaflets which coapt along a line of coaptation, the device including anexpandable, fluid-tight bladder configured to be deployed between valveleaflets of the heart valve. The bladder includes an upper portion thatextends into the atrium of the heart; a middle portion positionablewithin the line of valve leaflet coaptation. The middle portion providesa sealing surface for one or more of the leaflets. The bladder alsoincludes a lower portion that extends into the ventricle of the heart.The upper portion and lower portions expand and contract passively uponchanges in heart chamber pressure differential. The bladder alsoincludes a proximal anchoring mechanism having at least one pair ofangled clamping wires coupled to and extending proximally from aproximal end region of the bladder; and a sliding sleeve having an innerdiameter that is smaller than an outer diameter of the bladder in anexpanded configuration. The pair of angled clamping wires extend throughthe inner diameter of the sliding sleeve.

The device can also include an upper portion of the bladder that blocksa valve leaflet from flailing into the atrium. The bladder can befluid-filled. The bladder can further include one or more anchorssecuring the bladder to a location in the heart that is distal to anannulus of the valve. The one or more anchors can also secure thebladder to an annulus of the valve. The one or more anchors can securethe middle portion in a stationary position to the annulus of the valve.Expansion of the bladder can move the sliding sleeve in a proximaldirection and the inner diameter of the sliding sleeve urges the pair ofangled clamping wires towards one another. The pair of angled clampingwires can removably capture at least a portion of the atrial wallbetween them. The expandable bladder can further include a valve forselectively filling and depleting filling material into and out of thebladder such that the device can be repositioned, redeployed andremoved.

In another aspect, there is disclosed a device for treatingregurgitation through a gap in a valve in a heart that includes a framesized to fit within a heart chamber; a pair of arms moveably coupled tothe frame, the arms being moveable between a fluid flow-blockingposition during systole into a fluid flow-allowing position duringdiastole; an anchoring mechanism having a tether and an expandableportion positioned in the coronary sinus, wherein the tetherinterconnects the frame to the expandable portion; and a compliantmembrane covering the frame and at least a portion of the pair of arms.

The pair of arms can be coupled to the frame by a hinge. The frame canfurther include a stationary portion coupled to a proximal portion ofthe pair of arms. The stationary portion can be positioned above thelevel of the annulus. The stationary portion can have a long axisoriented orthogonal to the line of coaptation. The tether can connect toa region of the stationary portion near an outer edge of the gap. Thelong axis of the stationary portion can have a length sufficient tocontact an anterior and posterior annulus. The device can berepositioned, redeployed and removed from the heart.

In another aspect, there is disclosed a device for treatingregurgitation that includes a frame sized to fit within a heart chamber;a pair of arms moveably coupled to the frame, the arms being moveablebetween a fluid flow-blocking position during systole into a fluidflow-allowing position during diastole; an anchoring mechanism having atether and an anchor positioned in a wall of the ventricle, wherein thetether interconnects the frame to the anchor; and a compliant membranecovering the frame and at least a portion of the pair of arms.

The pair of arms can be coupled to the frame by a hinge. The frame canfurther include a stationary portion coupled to a proximal portion ofthe pair of arms. The stationary portion can be positioned above thelevel of the annulus and have a long axis oriented orthogonal to theline of coaptation. The tether can connect to the frame at a lowersurface of the stationary portion. The long axis of the stationaryportion can have a length sufficient to contact an anterior andposterior annulus. The device can be repositioned in the heart,redeployed in the heart and removed from the heart.

In another aspect, disclosed in a method for treating regurgitationthrough a valve in a heart. The method includes introducingpercutaneously a medical device system having a steerable guide catheterconfigured for delivery through the patient's vasculature to thevicinity of the gap; a retractable sheath moveably disposed over ablocker comprising an expandable, fluid-tight bladder, wherein theblocker is configured to be compressed by the sheath into a deliveryconfiguration into a patient's heart to a vicinity of a gap within theline of coaptation of the valve. The method also includes using theguide catheter to position a middle portion of the blocker within thegap along the line of coaptation, an upper portion of the blockerextending into the atrium of the heart; and a lower portion of theblocker extending into the ventricle of the heart. The method alsoincludes retracting the sheath to release the blocker from compressiveforces maintaining the blocker in the delivery configuration. The methodalso includes expanding the blocker such that the middle portion of theblocker provides a sealing surface for one or more of the valveleaflets. The upper portion and lower portions expand and contractpassively upon changes in heart chamber pressure differential. Themethod also includes detaching the blocker from the catheter; andretracting the catheter and the sheath from the heart.

The upper portion can block a valve leaflet from flailing into theatrium. The method can further include deploying one or more anchorsconfigured to secure the blocker to one or more locations in the heartthat are proximal to, distal to or at the level of the valve annulus.The one or more locations can be positioned distal to an annulus of thevalve or on the exterior of the heart near the apex. The one or moreanchors can include a screw-type anchor coupled to the blocker.Deploying the one or more anchors can include rotating the catheter toadvance the screw-type anchor into the one or more locations. The one ormore locations can be positioned on an annulus of the valve. The one ormore anchors can secure the middle portion in a stationary position tothe annulus of the valve. The one or more locations can be positionedproximal to an annulus of the valve. The one or more anchors can includeat least one pair of angled clamping wires coupled to and extendingproximally from the upper portion of the blocker; and a sliding sleevehaving an inner diameter that is smaller than an outer diameter of theupper portion of the blocker when the blocker is in an expandedconfiguration. The pair of angled clamping wires can extend through theinner diameter of the sliding sleeve. The method can also includeexpanding the expandable region of the blocker and moving the slidingsleeve in a proximal direction, the inner diameter of the sliding sleeveurging the pair of angled clamping wires towards one another. The pairof angled clamping wires can removably capture at least a portion of theatrial wall between them. The one or more locations can be positioned onthe septum between the left and right atria. Retracting the sheath torelease the expandable region of the blocker can expand the expandableregion. Expanding the blocker can include filling the blocker with afluid. Filling the blocker with a fluid can include extending thecatheter through a flow restriction mechanism in a neck region of theblocker to selectively fill the blocker with filling material deliveredthrough the catheter. The flow restriction mechanism can include aone-way valve such that detaching the blocker from the catheter includeswithdrawing the catheter from the one-way valve. The flow restrictionmechanism can include a snap ring surrounding the neck region of theblocker. Detaching the blocker from the catheter can include withdrawingthe catheter from the neck region and releasing the snap ring tocompress the neck region of the blocker.

Other features and advantages should be apparent from the followingdescription of various embodiments, which illustrate, by way of example,the principles of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic illustration of the left ventricle of a heartshowing blood flow during systole with arrows.

FIG. 1B shows a cross-sectional view of the heart wherein a flexiblestent is positioned at or near the mitral valve.

FIG. 2A shows a cross-sectional view of the heart showing one or moremagnets positioned around the annulus of the mitral valve.

FIG. 2B shows an annular band with magnets that can be positioned on themitral valve annulus.

FIG. 3 shows a cross-sectional view of the heart identifying locationsfor placement of valves.

FIG. 4 show a cross-sectional view of the heart with a pair of flapsmounted at or near the mitral valve.

FIG. 5A shows a schematic side view of the mitral valve leaflets with aflap positioned immediately below each leaflet.

FIG. 5B shows a downward view of the mitral valve with a pair ofexemplary flaps superimposed over the leaflets.

FIG. 5C shows a pair of mitral valve leaflet flaps having complementaryshapes.

FIG. 6A shows a cross-sectional view of the heart with a membrane ringpositioned at the mitral valve annulus.

FIG. 6B shows a schematic view of the membrane ring, which includes anannular ring on which is mounted a membrane.

FIG. 7A shows a schematic side view of the mitral valve leaflets failingto coapt.

FIG. 7B shows a schematic top plan view of the mitral valve with theleaflets in an abnormal closure state such that a gap is present betweenthe leaflets.

FIG. 7C shows a schematic side view of the mitral valve leaflets with ablocker positioned between the leaflets.

FIG. 7D shows a schematic top plan view of the mitral valve leafletswith a blocker positioned between the leaflets.

FIG. 8 shows a cross-sectional view of a heart with a blocker devicepositioned partially within the left ventricle and partially within theleft atrium.

FIGS. 9A-9B show schematic top plan views of the mitral valve leafletswith a blocker anchored between the leaflets during diastole andsystole.

FIGS. 10A-10D show a method of filling a fluid-tight blocker device.

FIGS. 11A-11C show various schematic views of another embodiment of ablocker.

FIG. 12A shows a schematic cross-sectional view another embodiment of ablocker during systole.

FIG. 12B shows a schematic cross-sectional view of the blocker from FIG.12A during diastole.

FIG. 12C shows a schematic top plan view of the blocker from FIG. 12A.

FIGS. 12D-12G show an exemplary delivery of the blocker from FIG. 12A.

FIG. 13A shows a schematic top view of the heart during systole withanother embodiment of a blocker in position.

FIG. 13B shows a schematic top view of the heart during diastole withthe blocker from FIG. 13A in position.

FIG. 13C shows a schematic cross-sectional view of the heart duringsystole with the blocker from FIG. 13A in position.

FIG. 13D shows a schematic cross-sectional view of the heart duringdiastole with the blocker from FIG. 13A in position.

FIG. 13E shows a schematic cross-sectional view of a heart duringsystole with the blocker device of FIG. 13A including a distal anchoringmechanism.

FIG. 13F shows a schematic cross-sectional view of a heart duringdiastole with the blocker device of FIG. 13A including a distalanchoring mechanism.

FIG. 14A shows a schematic top view of the heart during systole withanother embodiment of a blocker in position.

FIG. 14B shows a schematic top view of the heart during diastole withthe blocker from FIG. 14A in position.

FIG. 14C shows a schematic cross-sectional view of the heart duringsystole with the blocker from FIG. 14A in position.

FIG. 14D shows a schematic cross-sectional view of the heart duringdiastole with the blocker from FIG. 14A in position.

FIGS. 14E-14F show schematic perspective views of the blocker from FIG.14A in open and closed orientations.

FIGS. 15A-15D show schematic side views of a blocker having variousembodiments of a distal anchoring mechanism.

FIG. 15E shows a schematic side view of the blocker of FIG. 15Aincluding a proximal anchoring mechanism.

FIG. 15F shows a schematic cross-sectional view of a heart with theblocker device of FIG. 15E positioned within the mitral valve. Thechordae tendinae and papillary muscles are not shown for clarity.

FIG. 15G shows a schematic top plan view of the mitral valve of FIG.15E.

FIGS. 15H-15I show schematic, cross-sectional views of the heartillustrating a method of delivery of an anchored blocker.

FIGS. 16A-16C show schematic cross-sectional views of the heart withother embodiments of a blocker in position wherein the blocker includesvarious anchoring mechanisms.

FIG. 17A shows a schematic side view of a blocker having anotherembodiment of a proximal anchoring mechanism.

FIG. 17B shows a schematic cross-sectional view of a heart with theblocker device of FIG. 17A positioned within the mitral valve. Thechordae tendinae and papillary muscles are not shown for clarity.

FIG. 18A shows a schematic side view of a blocker having anotherembodiment of a proximal anchoring mechanism.

FIG. 18B shows the proximal anchoring mechanism of the blocker of FIG.18A taken along circle B-B.

FIG. 18C shows the proximal anchoring mechanism of FIG. 18B in a clampedstate.

FIG. 18D shows a schematic cross-sectional view of a heart with theblocker device of FIG. 18A positioned within the mitral valve. Thechordae tendinae and papillary muscles are not shown for clarity.

FIGS. 19A-19C show schematic cross-sectional views of a blocker devicehaving another embodiment of an anchoring system.

FIG. 20 shows a cross-sectional view of the heart wherein a one-wayvalve device is located in the left atrium.

FIG. 21A shows a prosthetic ring that is sized to fit within a mitralvalve.

FIG. 21B shows another embodiment of a prosthetic ring wherein a one-wayvalve is positioned inside the ring.

FIG. 22 shows a prosthetic with one or more tongues or flaps that areconfigured to be positioned adjacent the flaps of the mitral valve

FIG. 23A shows an exemplary embodiment of one or more clips that arepositioned on free edges of the leaflets.

FIG. 23B shows pair of leaflets with a magnetic clip attached to theunderside of each leaflet.

FIG. 23C shows the leaflets coapted as a result of the magneticattraction between the magnetic clips.

FIG. 23D shows a pair of leaflets with a single clip attached to one ofthe leaflets.

FIG. 24 shows a schematic, cross-sectional view of the heart with awedge positioned below at least one of the leaflets of the mitral valve.

FIG. 25A shows an artificial chordae tendon.

FIGS. 25B and 25C show attachment devices for attaching the artificialchordae tendon to a heart wall.

FIG. 26 shows a cross-sectional view of the heart with a first andsecond anchor attached to a wall of the heart.

FIG. 27 shows a catheter that has been introduced into the heart.

FIG. 28 shows a schematic view of a papillary muscle with a ringpositioned over the muscle.

FIG. 29 shows a cross-sectional view of the heart with one or moremagnets attached to a wall of the left ventricle.

FIG. 30A shows another embodiment of a procedure wherein magnets areimplanted in the heart to geometrically reshape the annulus or the leftventricle.

FIG. 30B shows the heart wherein tethered magnets are implanted invarious locations to geometrically reshape the annulus or the leftventricle.

FIG. 30C shows the heart wherein magnets are implanted in variouslocations to geometrically reshape the annulus or the left ventricle.

FIG. 31 shows another embodiment of a procedure wherein magnets areimplanted in the heart to geometrically reshape the annulus or the leftventricle.

FIG. 32 shows a cross-sectional view of the left ventricle with a tetherpositioned therein.

FIG. 33 shows a cross-sectional view of the left ventricle with adelivery catheter positioned therein.

FIG. 34 shows a cross-sectional view of the left ventricle with thedelivery catheter penetrating a wall of the left ventricle.

FIG. 35 shows a cross-sectional view of the left ventricle with thedelivery catheter delivering a patch to the wall of the left ventricle.

FIG. 36 shows a cross-sectional view of the left ventricle with thedelivery penetrating delivering a second patch.

FIG. 37 shows a cross-sectional view of the left ventricle with twotethers attached together at opposite ends from the patches mounted inthe heart.

FIG. 38 shows a cross-sectional view of the left ventricle with a needleor delivery catheter passed transthoracically into the left ventricle LVto deliver a patch to the exterior of the ventricular wall.

FIG. 39 shows a schematic, cross-sectional view of the left ventricle ina healthy state with the mitral valve closed.

FIG. 40 shows the left ventricle in a dysfunctional state.

FIG. 41 shows the left ventricle with a biasing member mounted betweenthe papillary muscles.

FIG. 42 shows the left ventricle with a suture mounted between thepapillary muscles.

FIG. 43 shows the left ventricle with a snare positioned around thechordae at or near the location where the chordae attach with thepapillary muscles.

FIG. 44 shows a leaflet grasping device that is configured to grasp andsecure the leaflets of the mitral valve.

FIGS. 45A-45C show the leaflet grasping device grasping leaflets of themitral valve.

FIG. 46 shows the left ventricle with a needle being advanced from theleft atrium into the left ventricle via the leaflet grasping device.

FIG. 47 shows the left ventricle with sutures holding the papillarymuscles in a desired position.

FIG. 48 shows a cross-sectional view of the heart with one or more clipsclipped to each of the papillary muscles.

FIG. 49 shows a cross-sectional view of the heart with tethered clipsattached to opposed walls of the left ventricle.

DETAILED DESCRIPTION

The present invention provides methods, systems, and devices for theendovascular repair of cardiac valves, particularly the atrioventricularvalves which inhibit back flow of blood from a heart ventricle duringcontraction (systole), most particularly the mitral valve between theleft atrium and the left ventricle. By “endovascular,” it is meant thatthe procedure(s) of the present invention are performed withinterventional tools, guides and supporting catheters and otherequipment introduced to the heart chambers from the patient's arterialor venous vasculature remote from the heart. The interventional toolsand other equipment may be introduced percutaneously, i.e., through anaccess sheath, or may be introduced via a surgical cut down, and thenadvanced from the remote access site through the vasculature until theyreach the heart. Thus, the procedures of the present invention willgenerally not require penetrations made directly through the exteriorheart muscle, i.e., myocardium, although there may be some instanceswhere penetrations will be made interior to the heart, e.g., through theinteratrial septum to provide for a desired access route.

While the procedures of the present invention will usually bepercutaneous and intravascular, many of the tools will find use inminimally invasive and open surgical procedures as well that includes asurgical incision or port access through the heart wall. In particular,the tools for capturing the valve leaflets prior to attachment can finduse in virtually any type of procedure for modifying cardiac valvefunction.

The atrioventricular valves are located at the junctions of the atriaand their respective ventricles. The atrioventricular valve between theright atrium and the right ventricle has three valve leaflets (cusps)and is referred to as the tricuspid or right atrioventricular valve. Theatrioventricular valve between the left atrium and the left ventricle isa bicuspid valve having only two leaflets (cusps) and is generallyreferred to as the mitral valve. In both cases, the valve leaflets areconnected to the base of the atrial chamber in a region referred to asthe valve annulus, and the valve leaflets extend generally downwardlyfrom the annulus into the associated ventricle. In this way, the valveleaflets open during diastole when the heart atria fill with blood,allowing the blood to pass into the ventricle.

During systole, however, the valve leaflets are pushed together andclosed to prevent back flow of blood into the atria. The lower ends ofthe valve leaflets are connected through tendon-like tissue structurescalled the chordae, which in turn are connected at their lower ends tothe papillary muscles. Interventions according to the present inventionmay be directed at any one of the leaflets, chordae, annulus, orpapillary muscles, or combinations thereof. It will be the generalpurpose of such interventions to modify the manner in which the valveleaflets coapt or close during systole so that back flow orregurgitation is minimized or prevented.

The left ventricle LV of a normal heart H in systole is illustrated inFIG. 1A. The left ventricle LV is contracting and blood flows outwardlythrough the tricuspid (aortic) valve AV in the direction of the arrows.Back flow of blood or “regurgitation” through the mitral valve MV isprevented since the mitral valve is configured as a “check valve” whichprevents back flow when pressure in the left ventricle is higher thanthat in the left atrium LA. The mitral valve MV comprises a pair ofleaflets having free edges FE which meet evenly to close, as illustratedin FIG. 1A. The opposite ends of the leaflets LF are attached to thesurrounding heart structure along an annular region referred to as theannulus AN. The free edges FE of the leaflets LF are secured to thelower portions of the left ventricle LV through chordae tendineae CT(referred to hereinafter as the chordae) which include plurality ofbranching tendons secured over the lower surfaces of each of the valveleaflets LF. The chordae CT in turn, are attached to the papillarymuscles PM which extend upwardly from the lower portions of the leftventricle and interventricular septum IVS.

While the procedures of the present invention will be most useful withthe atrioventricular valves, at least some of the tools describedhereinafter may be useful in the repair of other cardiac valves, such asperipheral valves or valves on the venous side of the cardiaccirculation, or the aortic valve.

The methods of the present invention can comprise accessing a patient'svasculature at a location remote from the heart, advancing aninterventional tool through the vasculature to a ventricle and/oratrium, and engaging the tool against a tissue structure which forms orsupports the atrioventricular valve. By engaging the tool against thetissue structure, the tissue structure is modified in a manner thatreduces valve leakage or regurgitation during ventricular systole. Thetissue structure may be any of one or more of the group consisting ofthe valve leaflets, chordae, the valve annulus, and the papillarymuscles, atrial wall, ventricular wall or adjacent structures.Optionally, the interventional tool will be oriented relative to theatrioventricular valve and/or tissue structure prior to engaging thetool against the tissue structure. The interventional tool may beself-orienting (e.g., pre-shaped) or may include active mechanisms tosteer, adjust, or otherwise position the tool.

Alternatively, orientation of the interventional tool may beaccomplished in whole or in part using a separate guide catheter, wherethe guide catheter may be pre-shaped and/or include active steering orother positioning means such as those devices set forth in United StatesPatent Application Publication Numbers 2004-0044350, 2004-0092962 andU.S. Pat. No. 7,226,467, all of which are expressly incorporated byreference herein. In all cases, it will usually be desirable to confirmthe position prior to engaging the valve leaflets or other tissuestructures. Such orienting step may comprise positioning the toolrelative to a line of coaptation in the atrioventricular valve, e.g.,engaging positioning elements in the valve commissures and confirmingthe desired location using a variety of imaging means such as magneticresonant imaging (MRI), intracardiac echocardiography (ICE),transesophageal echo (TEE), fluoroscopy, endoscopy, intravascularultrasound (IVUS) and the like.

In some embodiments, heart disease in general, and valve repair inparticular, are treated by targeting the pacing of the heartbeat. In oneembodiment, heart disease is treated by introducing one or more pacingleads into a heart chamber. The pacing leads are placed in contact witha heart muscle and are in electrical communication with a power source.The power source provides paced electrical stimuli to the heart muscle.The electrical stimuli are provided during or immediately after systoleto extend systolic contraction of the heart, thereby extending the rangeof systole during each heartbeat. This extension of systole extends theamount of time in which the heart muscle tightens when it wouldotherwise be relaxing, when there is most mitral regurgitation indiseased mitral valves.

Other embodiments are directed to annuloplasty to treat heart disease ingeneral and valve repair in particular. In one embodiment, showngenerally in FIG. 1B, a stent is used to treat the mitral valve. FIG. 1Bshows a cross-sectional view of the heart wherein a flexible stent 100is positioned at or near the mitral valve MV. The stent 100 is annularand is sized and shaped to be positioned on the annulus of the mitralvalve. The stent 100 can transition between a collapsed state of reducedsize and an expanded state of enlarged size relative to the collapsedstate.

The flexible stent 100 can be percutaneously introduced into anindividual's heart while being biased toward the collapsed state. Thestent is advanced partially through the annulus of the mitral valve sothat it is coaxially positioned within the annulus, as shown in FIG. 1B.The stent 100 is then secured to the annulus such that the stent exertsan inward force on the annulus thereby causing the annulus to resistdilation during diastole of the heart.

In yet another embodiment, a device is disclosed for treating the mitralvalve. The device can be a stent, such as the stent 100, that is sizedto fit coaxially within an annulus of a mitral valve. The stent includesa hollow frame. The frame can be annular such that it has across-sectional diameter that is sized such that an outer surface of theframe is in continuous coaxial contact with the annulus. The frame alsoincludes one or more anchors protruding from it for securing the stentto the annulus. The anchors can be prongs, barbs, protrusions, or anystructure adapted to secure the stent to the annulus. The stent isflexible between an expanded configuration and a contractedconfiguration and is biased toward the contracted configuration so thatit exerts an inward force on the annulus.

In one embodiment, the stent 100 is delivered using a delivery catheter10 that is advanced from the inferior vena cava IVC into the rightatrium RA. Once the catheter 10 reaches the anterior side of theinteratrial septum IAS, a needle 12 may be advanced so that itpenetrates through the septum at the fossa ovalis FO or the foramenovale into the left atrium LA. At this point, a delivery device can beexchanged for the needle and the delivery device used to deliver thestent 100. The catheter 10 can also approach the heart in other manners.

FIG. 2A shows a cross-sectional view of the heart showing one or moremagnets 205 positioned around the annulus of the mitral valve MV. Acorresponding method of treating heart disease involves the use ofmagnets. The method includes percutaneously introducing at least a firstmagnet 205 into an individual's heart and securing it to the mitralvalve MV annulus. At least a second magnet 205 is percutaneouslyintroduced into the heart and advanced so that it is within a magneticfield of the first magnet. The second magnet is secured to the heart.The polarity of one of the two magnets is then cyclically changed insynchronization with the heart beat so that the magnets attract andrepel each other in synchronization with the heart beat. The firstmagnet therefore moves in relation to the second magnet and exerts aninward closing force on the mitral valve during systole. The magnets 205can be positioned on an annular band 215 (shown in FIG. 2B) that issized and shaped to be implanted on the annulus of the mitral valve. Theband 215 can be, for example, a stent.

In one embodiment, the magnets 205 or the annular band 215 are deliveredusing a delivery catheter 10 that is advanced from the inferior venacava IVC into the right atrium RA, as described above with reference toFIG. 1. Any of the devices described herein can be percutaneouslydelivered into the heart by coupling the device to a delivery device,such as a steerable delivery catheter.

In yet another embodiment involving magnets, two or more magnets arepercutaneously introduced into an individual's coronary sinus such thatthey attract or repel each other to reshape the coronary sinus and anunderlying mitral valve annulus.

Other embodiments involve various prosthetics for treating heart diseasein general and defective or diseased mitral valves in particular. In oneembodiment, a method of treatment includes placing one or more one-wayvalves in one or more pulmonary veins of an individual either near theostium of the vein or at some point along the length of the PV. Valvesthat may be used, for example may be stentless valves such as designssimilar to the TORONTO SPV® (Stentless Porcine Valve) valve, mechanicalor tissue heart valves or percutaneous heart valves as are known in theart provided they are sized appropriately to fit within the lumen of thepulmonary vein, as shown in FIG. 3. In FIG. 3, the locations in the leftatrium LA where valves can be positioned in pulmonary vein orifices arerepresented by an “X”. In addition, certain venous valve devices andtechniques may be employed such as those described in U.S. Pat. Nos.6,299,637 and 6,585,761, and United States Patent Applications20040215339 and 20050273160, the entire contents of which areincorporated herein by reference. A valve prosthesis for placement inthe ostia of the pulmonary vein from the left atrium may be in the rangeof 6-20 mm in diameter. Placement of individual valves in the pulmonaryvein ostia (where the pulmonary veins open or take off from the leftatrium) may be achieved by obtaining trans septal access to the leftatrium with a steerable catheter, positioning a guidewire through thecatheter and into the targeted pulmonary vein, and deploying a valvedelivery catheter over the guidewire and deploying the valve out of thedelivery catheter. The valve may be formed of a deformable material,such as stainless steel, or of a self-expanding material such as NiTi,and include tissue leaflets or leaflets formed of a synthetic material,such as is known in the art. A line of +++++ symbols in FIG. 3represents a mid-atrial location above the mitral valve where a singlevalve can be positioned as disclosed later in this specification.

The following references, all of which are expressly incorporated byreference herein, describe devices (such as steerable catheters) andmethods for delivering interventional devices to a target locationwithin a body: United States Patent Application Publication Numbers2004-0044350, 2004-0092962 and U.S. Pat. No. 7,226,467.

FIG. 4 show a cross-sectional view of the heart with a pair of flapsmounted at or near the mitral valve. FIG. 5A shows a schematic side viewof the mitral valve leaflets LF with a flap 300 positioned immediatelybelow each leaflet. The flap 300 can be contoured so as to conform atleast approximately to the shape of a leaflet, or the flap 300 can bestraight as shown in FIG. 4. FIG. 5B shows a downward view of the mitralvalve with a pair of exemplary flaps superimposed over the leaflets LF.As shown in FIG. 5C, the flaps can have complementary shapes with afirst flap having a protrusion that mates with a corresponding recess ina second flap.

In corresponding method of treatment, shown in FIGS. 4 and 5C, a firstflap 300 with an attachment end 305 and a free end 310 is provided. Theattachment end 305 of the first flap 300 is secured to the inside wallof the ventricle below the mitral valve. A second flap 315 with anattachment end 320 and a free end 330 is provided and is also secured tothe inside wall of the ventricle below the mitral valve. The first andsecond flaps 300, 315 are oriented so that they face each other and thefree ends 310, 330 are biased toward each other and approximate againsteach other during systole. This system provides a redundant valvingsystem to assist the function of the native mitral valve.

In other embodiments, devices and methods that involve prosthetic discsare disclosed. For example, FIG. 6A shows a cross-sectional view of theheart with a membrane ring 610 positioned at the mitral valve annulus.FIG. 6B shows a schematic view of the membrane ring 610, which includesan annular ring on which is mounted a membrane. The membrane includes aseries of perforations 615 extending through the membrane surface. Oneor more anchor devices, such as prongs, can be located on the ring forsecuring the ring to the mitral valve.

In one embodiment, a device for treating heart disease in general anddefective or diseased mitral valves in particular includes a disc havinga ring, a membrane stretched across an opening of the ring, and one ormore anchors for securing the disc to an annulus of a mitral valve. Thedisc is sized to cover the annulus of the mitral valve, and the membraneincludes one or more perforations that permit one way fluid flow throughthe disc. Methods of treatment using the device are also provided.

Devices and methods are disclosed that involve a device known as ablocker or a bladder which improves the functioning of a heart valve byproviding a surface against which valve leaflets may coapt. The blockerdevice may be used to improve the functioning of any heart valve(tricuspid, aortic, mitral) though for the purpose of brevity mostexamples will be in relation to the mitral valve. A blocker device canbe used to treat mitral valve disease such as mitral regurgitation (MR).Blocker devices can also be used for treating other valve diseases suchas tricuspid valve regurgitation and aortic insufficiency.

As previously described functional mitral valve disease is usuallycharacterized by the failure of the anterior mitral valve leaflet tocoapt with (or “meet”) the posterior mitral leaflet during systole. Thiscan occur due to an enlarged ventricle or other impediment to theleaflets rising up far enough toward each other to close the gap or sealagainst each other during systole. FIG. 7A shows a schematic side viewand FIG. 7B shows a top plan view of a mitral valve with the leaflets LFin an abnormal closure state such that a gap G is present between theleaflets. Leaflets that fail to coapt can result in valve regurgitation(as represented by the arrow RF).

Upon positioning within, on, or around the valve, a blocker device canprovide a surface against which at least a portion of the valve leafletor leaflets can coapt. The blocker assists the valve preventingregurgitation by increasing the coaptation area of the valve leaflets LFand/or decreasing the coaptation depth of the leaflets LF. Increasingcoaptation of the valve can be accomplished by placing a blocker in thediseased valve orifice and providing a surface against which theleaflets LF can coapt therein closing the valve during systole. Theblocker can be conformable such that the leaflets press against and sealwith the blocker during systole. The blocker assists in closing thevalve without altering the shape of the annulus AN and/or repositioningthe papillary muscles PM. The blocker can conform to the leaflet shapeproviding better sealing to minimize and block mitral valveregurgitation.

FIGS. 7C and 7D show an embodiment of a blocker 630 positioned such thatthe blocker 630 is coaxially aligned between the leaflets LF along theline of coaptation of the leaflets LF. The blocker 630 can provide asurface against which at least a portion of the leaflets LF can seal andthus serve as a coaptation device for the leaflets. An atrial portion ofthe blocker 630 can extend into the left atrium, and a ventricularportion of the blocker 630 can extend into the left ventricle.

The configuration of the blockers described herein can vary. Forexample, the blocker can be solid, semi-solid or have a mesh-likeconfiguration. The blocker can also have a variety of shapes such thatit is optimized based on the geometry of the valve, the alignment of theleaflets and the size/shape of the valve orifice. For example, theblocker can have a spherical, ellipsoid, wing-like, t-shape, x-shape,y-shape, annular, sheet, rectangular, umbrella-shape or other geometry.It should be understood that any of the blocker embodiments describedherein may be used with any of the different anchoring mechanismsdescribed herein. For the sake of brevity, Applicants will omit anexplicit description of each combination of blocker embodiment andanchoring mechanism. Additionally, Applicants describe herein differentmethods for accessing heart valves and for implanting the blocker devicewithin the heart. The different blocker devices are amenable to severaldifferent methods of access and implantation. Applicants will providerepresentative descriptions of how to access the heart vale and implantthe blocker. However, for the sake of brevity, Applicants will omit anexplicit description of each method of access/implantation with respectto each blocker embodiment.

Advantageously, the blocker can be expandable or can include anexpandable region. The expandable region can be self-expanding oractively expanded such as by fluid filling. As will be described in moredetail below, a blocker can include a “balloon”-type, compliantexpandable region such as a sealed, fluid-filled bladder. A blocker caninclude an expandable frame or mesh covered by a compliant material(“covered stent” type blocker). A blocker can include an expandableregion composed of a compressed, sponge-like material. A blocker caninclude an expandable region that takes on a blocking geometry, forexample, a T-shape or other shape with an enlarged “head” at the atrialside of the valve. A blocker can include an expandable region that isdynamic and moves with the changes in pressure and flow of thediastolic/systolic cycle. A blocker can include an expandable regionthat sits like a diaphragm across the valve to block regurgitation.Features of the various blockers described herein can be used incombination with any of the embodiments described herein.

Materials suitable for construction of the blocker can vary, forexample, synthetic polymers, biological polymers, metals, ceramics, andbiological materials. Suitable synthetic polymers can includefluoroethylenes, silicones, urethanes, polyamides, polyimides,polysulfone, polyether ketones, polymethyl methacrylates, and the like.Suitable metals can be composed from a variety of biocompatible elementsor alloys. Examples include shape-memory metal (e.g. Nitinol), titanium,Ti-6AL-4V, stainless steel alloys, chromium alloys, and cobalt alloys.The materials can also be subjected to surface modification techniquesto make them selectively bioreactive or non-reactive, includingtexturing, surface coatings, electrical modification, coating orimpregnation of biologically derived coatings and a variety ofgrowth-healing modifications.

Blocker embodiments described herein can be delivered usinginterventional tools, guides and supporting catheters and otherequipment introduced to the heart chambers from the patient's arterialor venous vasculature remote from the heart. The blockers describedherein can be compressed to a low profile for minimally-invasive orpercutaneous delivery. They can be advanced from the remote access sitethrough the vasculature until they reach the heart. For example, theblockers can be advanced from a venous site such as the femoral vein,jugular vein, or another portion of the patient's vasculature. It isalso appreciated that blockers can be inserted directly into the bodythrough a chest incision. A guidewire can be steered from a remote sitethrough the patient's vasculature into the inferior vena cava (IVC)through the right atrium so that the guidewire pierces the interatrialseptum. The guidewire can then extend across the left atrium and thendownward through the mitral valve MV to the left ventricle. After theguidewire is appropriately positioned, a catheter can be passed over theguidewire and used for delivery of a blocker device.

Blocker embodiments described herein can also be delivered using acatheter advanced through retrograde access through, for example anartery, across the aortic arch and the aortic valve and to the mitralvalve by way of the ventricle. Alternative delivery methods of blockerembodiments described herein can include inserting the blocker through asmall access port such as a mini-thoracotomy in the chest wall and intothe left ventricle apex. From there, the blocker can be advanced throughthe left ventricle into the left atrium. It should be appreciated thatthe device can also be delivered via the left atrial wall as well.Positioning of the tool and/or blockers described herein can beconfirmed using a variety of imaging means such as magnetic resonantimaging (MRI), intracardiac echocardiography (ICE), transesophageal echo(TEE), fluoroscopy, endoscopy, intravascular ultrasound (IVUS) and thelike.

Following insertion, the blocker can be anchored and/or expanded intoposition. A sheath can be used to compress the blocker during insertionsuch that upon retraction the sheath allows for expansion of theblocker. Expansion mechanisms of the expandable portion of the blockercan vary. In an embodiment, expansion of the blocker can occur through apassive, self-expansion mechanism. In another embodiment, the blockercan be actively expanded such as by infusing a filling fluid through thecatheter lumen into a sealed expandable portion. Upon expansion of theblocker, mitral regurgitation and ventricular filling can be assessed todetermine whether expansion of the blocker is sufficient. The blockercan be reversibly coupled to the catheter or sheath such that theblocker can be retracted back into the catheter or advancing the sheathif repositioning is necessary. If the result is not satisfactory, theblocker can be retracted, repositioned, re-deployed or removed.

If the blocker includes one or more anchors, materials suitable for theconstructions of the anchors can vary as well. Materials can includebiocompatible and/or coated, impregnated, or otherwise treated with amaterial or other materials to impart biocompatibility, shape-memorymetal (e.g. Nitinol and Nitinol alloys), stainless steel and stainlesssteel alloys, titanium and titanium alloys, cobalt-chrome alloys,wire-mesh, and the like. The anchor can also be constructed of materialssuch as thread made of, for example, nylon, braided nylon, PTFE, ePTFE,medical-grade sutures and the like or combinations of the above.

FIG. 7D illustrates an embodiment of a blocker 630 that is attached oranchored to the mitral valve at opposite edges E of the gap G (shown inFIG. 7B). The blocker devices described herein can be attached oranchored to various locations adjacent to or on the valve being treated.It should also be appreciated that the blocker device can be positionedwithout anchors. The blocker devices described herein can includeproximal anchor mechanisms that secure to tissues at or superior to thelevel of the valve, for example the atrium, coronary sinus, interatrialseptum or upper surface of the annulus or valve leaflets. The proximalanchors can act to suspend the blocker between the valve leaflets. Theblocker devices described herein can include distal anchor mechanismsthat secure to tissues at or inferior to the level of the valve, forexample, the ventricle wall, interventricular septum, or the lowersurface of the annulus or valve leaflets. In another embodiment, adistal portion of the blocker can be secured to the chordae tendinaeand/or the papillary muscle. In another embodiment, the blocker issecured by a combination of anchoring mechanisms, for example bothproximally and distally to the level of the valve. It should beappreciated that a combination of anchor types can be used and that theanchors can secure the blocker to different portions of the heartincluding the external wall of the heart.

The timing of the deployment of the anchoring mechanisms, if used, canvary. For example, the anchoring mechanisms can be deployed prior to orafter the blocker is in place between the leaflets. For example, in oneembodiment the blocker includes a distal coiled screw anchor that isscrewed into the myocardium of the left ventricle, for example, byrotating the catheter prior to placement of the blocker between theleaflets. In another embodiment, the blocker includes a chordalattachment anchor that is delivered prior to deployment of the blockerfrom the catheter tube. In these examples, once the anchors are in placethe blocker is positioned between the leaflets and expanded or allowedto expand. It should be appreciated, however, that expansion can occurprior to anchoring the blocker or that no anchoring mechanism be used atall. It should also be appreciated that the anchoring mechanisms can beadjusted after deployment such that they release the heart tissue, forexample, if the results of the blocker are not satisfactory. In anembodiment, the catheter can be used to rotate the blocker and unscrewthe coiled anchors from their tissue attachment. Thereafter the devicecan be re-positioned, re-deployed or removed. If the result issatisfactory, the catheter can be detached from the blocker andwithdrawn.

FIG. 8 shows an embodiment of a blocker that is an expandable blocker600. The blocker 600 can be a fluid-tight expandable element or bladderthat can be filled with a fluid, including a liquid or a gas. Theblocker 600 can be positioned partially within the left ventricle andpartially within the left atrium. The bladder 600 can be placed acrossthe mitral valve MV between the left atrium LA and the left ventricleLV. Upon compression of the left ventricle LV during systole, the volumeof the blocker 600 can expand on the left atrial LA side of the heart,providing a baffle or sealing volume to which the leaflets of the mitralvalve coapt. The blocker 600 also can block the flail and billowing of aleaflet into the left atrium. The blocker 600 can also have enlargedportions on both the atrial and ventricular sides with a generallynarrower transition zone therebetween. The enlarged portions canmaintain the blocker in position and prevent the blocker from migratinginto the atrium or the ventricle. The blocker 600 can also be formed ona cage or other infrastructure to position it within the line ofcoaptation of the mitral valve.

The blocker 600 can include one or more anchors for securing the blockerto an annulus of a mitral valve. In an embodiment, the mid portion ofthe blocker 600 can be secured to the annulus of the mitral valve suchthat the mid-portion remains stationery while the atrial and ventricularportions expand and contract passively between the atrium and ventricledue on pressure differentials during systole and diastole. FIGS. 9A-9Bshows an embodiment of a blocker 600 that includes an anchor 602 on eachend of the blocker 600. The anchor(s) 602 can be positioned near the midportion or narrower portion of the blocker 600 and secure the blocker600 to the annulus.

As mentioned above, the blocker 600 can be an expandable element thatcan be filled with a fluid, such as a liquid, gel, gas or othermaterial. FIGS. 10A-10D illustrate methods of filling the blocker 600upon implantation between the valve leaflets. The blocker 600 caninclude a neck region 601 near its proximal end having a valve 603through which filling material can be infused. The valve mechanism orconfiguration can vary. In an embodiment shown in FIG. 10A-10B, thevalve 603 can be a duckbill valve having one or more flexible “flaps”that close and seal against one another. The delivery catheter or afiling tube 604 can be inserted through the valve 603 such that anopening at the distal end of the filling tube 604 extends within a lumen605 of the blocker 600. Upon filling of the blocker 600 with material,the filling tube 604 can be removed from the valve 603 by withdrawing itin a proximal direction. The flaps of the valve 603 can then close andprevent escape of the filling material delivered to the lumen 605 of theblocker 600. The filled lumen 605 of the blocker 600 can have a pressurethat is higher than the pressure on the proximal side of the valve whichcan aid in urging the valve flaps towards one another and closing thevalve such that filling material does not flow out of the blocker 600 asshown in FIG. 10B. FIGS. 10C-10D illustrate an alternative valve designwhich involves the use of a spring clip 606. In this embodiment, theblocker 600 has a neck region 601 that is clamped on an external surfaceby a clip 606 or other spring-loaded mechanism. The clip 606 can beinitially held open, for example, by the catheter or filling tube 604inserted through the neck of the blocker 600. After filling of theblocker 600 with material, the filling tube 604 can be removed and theclip 606 spring closed around the neck region 601 of the blocker 600.The clip 606 in its closed position can seal off the proximal end of theblocker 600 (see FIG. 10D).

FIGS. 11A-11C show another embodiment of a blocker 3800. The blocker3800 can be oriented along the leaflet coaptation. The blocker 3800 canextend a portion of or the full-width of leaflet coaptation. The blocker3800 can allow for both leaflets LF to coapt to and open away from theblocker 3800. The blocker 3800 can include a central bar 3805 that canoptionally extend downward through the gap G between the leaflets LF.The blocker 3800 can include anchors 3820 that upon positioning withinthe valve are oriented near both leaflet commissures C and push outwardagainst the atrial wall. The anchors 3820 can have one or morefrictional elements to improve their interface with the surroundinganatomy. The blocker 3800 also can include an expandable anchor ring3810 (either self-expanding or balloon-type expanding) coupled to thebar 3805 and/or the anchors 3820 that extends around the circumferenceof the annulus AN. The circumferential anchor ring 3810 can expand andpush out against the atrial wall at the annulus level thereby retainingthe bar 3805 in position between the leaflets LF. In an embodiment, theblocker 3800 and anchor ring 3810 can include a self-expanding meshcovered with a compliant material for improved sealing and leafletcoaptation. In another embodiment, the blocker 3800 and anchor ring 3810are balloon-expanded or filled with a fluid material such as two-partepoxy, resin, polymer, hardening or hardenable material, Hydrogelmaterial, saline or other material. In another embodiment, the blocker3800 and anchor ring 3810 are made of a compressed, sponge-like materialthat expands. Various features of the blocker 3800 can be used incombination with any of the blocker embodiments described herein.

FIGS. 12A-12G show another embodiment of an expandable blocker. In thisembodiment, the blocker 4000 can include a frame 4005 having an upperportion 4010 that is oriented within the left atrium above the level ofthe annulus, a lower portion 4020 that is oriented within the leftventricle below the level of the annulus and a middle portion 4025 thatis oriented at the level of the annulus. The frame 4005 can be generallyflexible and can be made from shape-memory metal (e.g. Nitinol) or anexpandable wire mesh or the like. The frame 4005 can be covered by amembrane or coating 4030 that can be constructed of a flexible,compliant material such as silicone rubber or a saline-filled balloonstructure. It should be appreciated that the frame 4005 need not beflexible. The blocker 4000 can be positioned over the gap G between theleaflets LF along the line of coaptation C. The upper portion 4010 ofthe frame 4005 can rest above the valve plane such that it contacts orrests upon the anterior and posterior annulus AN. The lower portion 4020of the frame 4005 can extend under the valve leaflets such that it doesnot come in contact with the annulus AN as shown in FIG. 12A-12C.

The frame 4005 can be held in place during systole and diastole due to aspring force of the frame 4005. The blocker 4000 can plug the gap Gbetween the anterior and posterior leaflets LF, but does not requiresutures or anchors due to the configuration of the upper and lower frameportions 4010, 4020 relative to the anatomy. The upper portion 4010 ofthe frame 4005 can provide anchoring support through its interactionwith the annulus wall and prevent the blocker 4000 from moving duringheart function. The lower portion 4020 of the frame 4005 can capture theleaflets LF and close the gap G between the leaflets LF as well askeeping the blocker 4000 in position within the valve. It should beappreciated that the frame 4005 can also be held in place using one ormore anchors.

In an embodiment, the lower portion 4020 of the blocker 4000 can move inresponse to the changes in pressure during the diastolic/systolic cyclesuch that the leaflets LF are captured between the lower portion 4020and the upper portion 4010 of the frame 4005. The lower portion 4020 ofthe frame 4005 can include a pair of arms 4035, 4040 that move upwardand downward. During systole the arms 4035, 4040 move upward flatteningout against the valve leaflets LF trapping them between the arms 4035,4040 and the upper portion 4010 of the frame 4005. During diastole, theblocker 4000 arms 4035, 4040 can spring back to a relaxed position. Itshould be appreciated that movement of the blocker arms 4035, 4040 isoptional and that the arms 4035, 4040 can also be fixed in orientationand not move during the diastolic/systolic cycle.

FIGS. 12D-12G illustrate a method of delivery of the blocker 4000.During delivery, the blocker 4000 can be oriented within the catheter4045 such that the upper portion 4010 and lower portion 4020 are eachcompressed into a low profile. The catheter 4045 can be fed through thevalve such that upon withdrawal of the catheter 4045 the arms 4035, 4040of the lower portion 4020 can relax into position below the leaflets LF.After the lower portion 4020 is deployed, the catheter 4045 can befurther withdrawn such that the upper portion 4010 can be deployed andrelaxes into position above the valve leaflets LF. The diameter of theupper portion 4010 prevents it from passing through the valve.

Other embodiments of blockers described herein also use dynamic methodsof blocking regurgitation through the valve such as by passivelychanging their shape or changing their orientation during systole anddiastole using the forces of the cardiac circulation to effect the shapeor orientation change. FIGS. 13A-13F illustrate an embodiment of ablocker 4100 having a folded configuration and including flaps or armsthat can “tent” or fill during systole. During systole, as blood flowsagainst the closed mitral valve, the flaps of the blocker 4100 open upand tent as they fill with the flow blocking mitral regurgitation.During diastole, blood flows from the LA into the LV through the openmitral valve. The flaps move downward and the blocker 4100 folds toallow blood to flow past the blocker 4100 passively allowing diastolicflow. It should be appreciated that the blocker 4100 can alsoincorporate a hinge feature to aid in the folding of the flaps on eitherside of the central region. In such an embodiment, the flaps canpassively articulate or rotate about the pivot axis of the hinge whilethe hinge remains fixed with the cardiac circulation.

The blocker 4100 can include a frame constructed of a flexible material,for example, the blocker 4100 can be constructed of a shape-memory metal(e.g. Nitinol) or a flexible semi-rigid polymer such as Nylon or PTFE.The blocker 4100 can be formed into a flexible sheet or other shape. Theblocker frame can be covered by a compliant membrane or other materialto improve sealing function. As mentioned above, the frame can includethe pair of arms positioned at least in part below the level of theannulus. The frame can be moveable between a fluid flow-allowingposition and a fluid flow-blocker position in response to changes inheart chamber pressure during the heart cycle. The pair of arms can tentupwards against the lower surface of a valve leaflet, for example duringsystole into the fluid flow-blocking position. The pair of arms cancollapse downward away from the lower surface of the valve leaflet, forexample during diastole into the fluid flow-allowing position.

The blocker 4100 can be tethered to one or more anchors 4105. The one ormore anchors 4105 can include a tether connecting a portion of the frameof the blocker 4100 to an expandable portion of the anchor 4105positioned, for example, within the coronary sinus (see FIGS. 13A-13B).The tether can also connect the blocker 4100 to an anchor that can bepositioned distally, for example within the left ventricular wall (seeFIGS. 13E-13F). The tether can connect to the frame, for example at aportion aligned near an outer edge E of the gap G. The frame can includea stationary portion coupled to a proximal portion of the pair of arms.The stationary portion can be positioned above the level of the annulusand have a long axis oriented orthogonal to the line of coaptation. Thetether can connect to the frame at the stationary portion near a regionaligned near an outer edge of the gap. The tether can connect to theframe at a lower surface of the stationary portion, for example, wheninterconnecting the blocker to a location distal to the valve such asthe wall of the left ventricle.

In another embodiment, best seen in FIGS. 14A-14F, the blocker 4200 canact as a “baffle” and change orientation, such as by swiveling, rotatingor pivoting, thereby opening and closing the valve. The change inorientation of the blocker 4200 can be passive in that the blocker opensand closes as a result of the change in pressure and flow reversalduring the systolic/diastolic cycle. Alternatively, the orientationchange of the blocker 4200 can be semi-active, for example, aspring-loaded mechanism that orients the blocker 4200 in a firstdirection and changes orientation, for example, due to blood flow in asecond, opposite direction. In an embodiment, the blocker 4200 canoperate as a butterfly valve.

The blocker 4200 can be a planar structure having a rectangular shapesuch that it is longer than it is wide (see FIGS. 14E and 14F). Duringsystole, the blocker 4200 can be aligned such that the long axis of theblocker 4200 spans between the leaflets LF and blocks the flow of bloodthrough the gap G (see FIGS. 14A and 14C). During diastole, the blocker4200 can swivel approximately 90 degrees such that the long axis of theblocker 4200 aligns with the gap G and flow is allowed through the valve(FIGS. 14B and 14D). The blocker 4200 swivels between a closed positionduring systole and an open position during diastole regulating flowthrough the valve as a result of blood flow during the cardiac cycle.

The blocker 4200 can be tethered to an anchor 4205 such as a stent orsimilar structure. The blocker 4200 can be constructed of abiocompatible material such as a metal or polymer, for example animplantable stainless steel, titanium, or Nitinol. The blocker 4200 canbe generally rigid and the anchors 4205 can be flexible. Variousfeatures of the blockers 4100, 4200 can be used in combination with anyof the blocker embodiments described herein.

As mentioned previously, the blockers described herein can include oneor more anchoring mechanisms. The blocker devices described herein caninclude proximal or mid-portion anchor mechanisms that can be secured tothe atrium or to the septum or to the leaflets or annulus. In otherembodiments, the blocker can be secured distally such as to theventricle or the chordae tendinae or the papillary muscle. It should beappreciated that a combination of anchoring mechanisms can beincorporated and that the anchors can secure the blocker to differentportions of the heart. The blocker devices described herein can also beused without the aid of an anchor.

FIGS. 15A-15D illustrate blocker embodiments incorporating distalanchors. As noted previously, the distal anchors illustrated in FIGS.15A-15D can be used with any of the blocker concepts described in thisdisclosure, and explicitly not limited to the blocker 4301 depicted inFIG. 15A.

FIG. 15A illustrates a blocker 4300 that includes a distal anchor 4305that is a coiled screw type of anchor, which can embed into the heartwall. In another embodiment shown in FIG. 15B, the blocker 4300 includesmultiple spring wire supports 4310 that prop up the expandable region4301 from the coiled screw anchor 4305. The spring wire supports canprovide additional axial stability. As shown in FIG. 15C, additionalaxial stability can also be provided to the blocker 4300 by additional“leg” supports 4315 as an alternative to spring wire supports 4310.Another embodiment of a blocker shown in FIG. 15D, can include anexternal anchor 4320 that can be used, for example, with a blockerdelivered through the left ventricular wall near the apex of the heartto the exterior of the heart.

In an embodiment shown in FIGS. 15E, 15F and 15G, the blocker 4500includes one or more support wires 4510 extending proximally from theexpandable region 4501 in addition to the distal anchor 4505. Thesupport wires 4510 can be sized to engage the muscular annulus aroundthe mitral valve MV as well as tissue of the left atrium LA. The supportwires 4510 can be sharp or include barbs 4515 to hold onto the tissue.During delivery, the support wires 4510 can be retracted within a sheathor catheter and then relax or spring outward upon retraction of thesheath to engage the annulus or left atrium. The support wires 4510 canbe sized to engage the annulus and/or the left atrial tissue.

FIGS. 15H-15I show method of delivery of an anchored blocker, such asthe blockers shown in FIGS. 15A-15G, using a catheter 4045 and aretractable sheath 4110 compressing the expandable region 4301 of theblocker 4300 to a delivery configuration inside an inner lumen of thesheath 4110. The catheter and sheath system having a compressed blockertherein can be advanced from a venous site, such as accessed from afemoral vein through the inferior vena cava IVC and across theinteratrial septum to the mitral valve as is described herein. Thecatheter 4045 can be positioned using guidance methods such asechoguidance or other guidance method known in the art. The distalanchor of the blocker 4300 can extend out the distal end of theretractable sheath 4110 and come into contact with the ventricle wallupon advancement of the blocker 4300. The catheter 4045 can be rotatedto advance the anchor 4305 into the left ventricle myocardium. Theanchor 4305 can be embedded in the ventricle wall. An anchor 4320 canalso be implanted that it is external to the heart (see FIG. 15I). Analternate delivery method can include through a small access port suchas through the chest wall, such as through a mini-thoracotomy, and intothe apex of the left ventricle. The device can be advanced from the leftventricle into the left atrium and then the sheath retracted to open theblocker. The surgeon can then implant an external anchor 4320 uponpositioning the blocker between the valve leaflets and then close theaccess ports.

As shown in FIG. 15I, the blocker 4300 can self-expand upon retractionof the sheath 4110. The leaflets can then coapt against the blocker andprevent mitral regurgitation (MR). If the MR result is unsatisfactory insome way, the sheath 4110 can be re-advanced to compress the expandableportion 4301 of the blocker 4300. The catheter 4045 can then be rotatedto either unscrew or screw the distal anchor 4305 and the distancebetween the blocker 4300 and the base of the ventricle wall modified.The blocker can be re-positioned, re-deployed and removed. If the MRresult is satisfactory, the blocker can be detached from the catheterand the catheter and sheath retracted and withdrawn from the patient.

The expandable regions 4301, 4501 of the blockers 4300, 4500 describedabove can be inflatable bladders or made from a compliant material. Itshould be appreciated that other configurations of expandable regionsare considered. It should also be appreciated that the anchors andsupports described with respect to the blocker embodiments of FIGS.15A-15I can be used with other embodiments of blockers described herein.

FIGS. 16A-16C show more embodiments of a blocker 4400 having a distalanchoring mechanism 4405. As shown in FIG. 16A, the blocker 4400 is heldin place by distal anchors 4405 that attach to the chordae tendinae CTand/or papillary muscle PM. The anchors 4405 can include variousattachments 4410 including loops that wrap around the CT or clips thatattach to the PM. The embodiment of FIG. 16B shows a blocker 4400 wherethe geometry of the proximal region of the blocker 4400 further supportsthe blocker and prevents it from passing through the leaflets LF fromthe atrial side. This embodiment also shows an anchor 4405 (in this casea suture line attachment that attaches to the papillary muscle PM). Theanchors 4405 and/or attachments 4410 can be shape-memory metal (e.g.Nitinol) with coil set shape that wrap around the chordae.Alternatively, the blocker 4400 can incorporate a rail system such thatafter the anchors 4005 are in place the blocker 4400 can be advancedover a guide wire or other rail system to slide the blocker 4400 intothe desired location. The rail system can be used to lock on the anchors4405 upon expansion. Various blocker anchoring mechanisms can be usedand can be used in combination with any of the blocker embodimentsdescribed herein.

FIG. 16C shows an embodiment of a blocker 4400 incorporating anotherembodiment of a distal anchor system or support structure 4415. Thesupport structure 4415 (e.g. wires, plastic elements or inflatable legs)can be advanced distally from the blocker 4400 such that it contacts theinner wall of the left ventricle LV near the apex AX. The supportstructure 4415 can curve back around up toward the valve structure,pressing against and pushing up from the apex AX and against theventricle wall. The support structure 4415 can terminate under theleaflets LF against the ventricle wall. The blocker 4400 can lock theposition of the support structure 4415 upon expansion.

The blockers of FIGS. 16A-16C can be contained within a catheter orsheath during delivery and advanced to the left atrium. The distalanchors 4405 can initially wrap around (or clip or pierce or insert,depending on the embodiment used) the chordae and/or papillary musclesPM before the blocker 4400 exits the catheter guide tube. The blocker4400 can self-expand upon retraction of the catheter or sheath or beinflated prior to retraction of the catheter or sheath as describedabove. Expansion of the blocker 4400 can lock into position the chordaeor PM attachment. Deflation or re-compression of blocker 4400 can allowmovement and repositioning of the blocker. It should be appreciated thatthe catheter could also be advanced from a femoral site over the aortathrough the aortic valve and retrograde to the mitral valve. The distalanchors 4405 can grasp and wrap around the chordae according to avariety of methods, for example such as described in U.S. PublicationNo. 2004-0030382, which is incorporated herein by reference in itsentirety.

Blockers described throughout this disclosure can include a combinationof anchor mechanisms. For example, the blockers can include either orboth distal and proximal anchors. Such a combination of anchors providesadditional axial stability, adjustability and positioning. The distalanchors as described above can attach, for example, to the ventriclewall or papillary muscle or chordae and the like. The proximal anchorsof the blocker can attach to the annulus, the atrial wall, valveleaflets and/or the interatrial septum.

In another blocker embodiment shown in FIG. 17A-17B, the blocker 4600includes one or more of a proximal anchor mechanism 4610 and/or a distalanchor 4605. The proximal anchor can have a “clam-shell” or“double-umbrella” design configured to engage the septum between theleft and right atria in the heart. The illustration provided in FIG. 17Aincludes both proximal and distal anchors; however, the use of only aproximal or only a distal anchor is contemplated. In an embodimentincluding a proximal anchor 4610, a wire 4615 extends from theexpandable region 4601 to one or more septal anchors 4620. Thismechanism provides adjustability of position to optimize the result. Forexample, the length of the wire 4615 can be adjusted by applying aproximally-applied force such that the wire 4615 slides in a proximaldirection through the septum and the septal anchors 4620. A crimp orother clamping device can be advanced in a distal direction over thewire 4615 until it abuts a septal anchor 4620, for example the septalanchor 4620 in the right atrium. The crimp can be deployed such that itis affixed to a portion of the wire 4615 near the septal anchor 4620 andprevents the wire 4615 from sliding back through the septal anchors4620. The wire 4615 can extend from a proximal portion of the expandableregion 4601 of the blocker 4600. Alternatively, the wire 4615 can extendfrom the distal anchor 4605, through the expandable region 4601 and outthe proximal end of the blocker 4600. In this embodiment, adjustment ofthe wire 4615 can also adjust the length of the wire 4615 between theanchor 4605 and the expandable region 4601 of the blocker 4600.

An alternate proximal anchoring mechanism is shown in FIGS. 18A-18C). Inan embodiment, an expandable blocker 4701 can include a proximal anchormechanism 4710. As best shown in FIGS. 18B and 18C, the proximal anchormechanism 4710 can include a sleeve 4715 that can be advanced and bringstogether one or more pairs of sharp angled wires 4720 that grab ontomyocardium in either the ventricle or atrium or both. The blocker 4701can be expanded such as by inflation such that it urges the sleeve 4715in a proximal direction (arrow A). As the sleeve 4715 moves in theproximal direction, the inner walls of the sleeve 4715 presses againstthe pairs of angled wires 4720 moving them towards one another. As theangled wire pairs 4720 move together any tissue positioned therebetweenwill be captured and the device clamped in place. The diameter of theexpanded blocker 4701 can be larger than the inner diameter of thesleeve 4715. This prevents the sleeve 4715 from being retracted in thedistal direction back over the blocker 4701. Thus, the expanded blocker4701 can simultaneously block regurgitation through the valve leaflets,deploy the proximal anchor and lock the proximal anchor in place.

To re-position the blocker system, the expandable blocker 4701 can bedepleted of filling material such that the outer diameter of theexpandable blocker 4701 is reduced and the sleeve 4715 can be withdrawnor retracted over the outer diameter of the blocker 4701. The embodimentof FIG. 18A is shown having a distal anchor 4705, but it should beappreciated that the embodiment need not include a distal anchor.

FIG. 18D shows another embodiment of a blocker 4700 incorporating both aproximal anchoring mechanism 4710 as well as a distal septal anchor4725; however, it should be understood that the blocker may include onlythe distal anchor 4725, only the proximal anchor 4710, or both proximaland distal anchors.

FIGS. 19A-19C show another embodiment of a proximally-anchored blockersystem 4800. The blocker system 4800 includes a blocker 4801 which maybe any of the blockers disclosed throughout this disclosure. Thus, theblocker 4801 may be formed of a resilient material and/or may be aliquid or gas-filled bladder. Upon positioning of the blocker 4801between the leaflets such that the blocker 4801 provides a desiredamount of coaptation between the leaflets, an anchor system 4810 can beactuated. The anchor system 4810 can include an anchor wire lock ring4815, a plurality of support arms 4820 and a blocker lock ring 4825.

The anchor system 4810 deploys in a manner similar to an umbrella'sarms. The anchor wire lock ring 4815 can be slid proximally and distallyto spread or retract the support arms 4820. The support arms 4820 can bemade of a shape memory material such as Nitinol or the like such thatthe support arms are biased to extend or spread. Alternatively, abiasing member (not illustrated) such as a spring or the like can beused to bias the support arms 4820 to extend. Further still, the anchorsystem 4810 can omit a biasing member such that support arms 4820 can bemanually opened by extending the ring 4815.

The support arms 4820 can anchor to the atrial side of the valve such asby grasping or penetrating the annulus or other structures near thevalve, such as with barbs 4818 or other features that improve the gripof the support arms 4820 to the adjacent anatomy. The support arms 4820can also anchor due to a spring force or pushing out against the atrialwall. The support arms 4820 can also have a length that is adjustable,for example, the support arms 4820 can slide through the anchor lockring 4815 such that arm length can be adjusted for proper contact withthe adjacent structures. Such a configuration can be self-adjusting. Theanchor lock ring 4815 can lock onto the blocker lock ring 4825 to fixthe blocker 4800 in its deployed state, such as by a snap-lock typeconfiguration.

FIG. 20 shows a cross-sectional view of the heart wherein a one-wayvalve device 700 is located in the left atrium. The valve device isrepresented schematically in FIGS. 21A-B. A corresponding method oftreating heart disease includes introducing a one-way valve device 700into the left atrium of an individual's heart proximal the mitral valve.The valve device 700 is configured to permit fluid flow in one directionwhile preventing fluid flow in an opposite direction. The valve devicecan have various structures. For example, the device can comprise avalve that is mounted on a stent that is sized to be positioned in theleft atrium. Valves that may be used, for example may be stentlessvalves such as the TORONTO SPV® (Stentless Porcine Valve) valve,mechanical or tissue heart valves or percutaneous heart valves as areknown in the art. The outer wall of the one-way valve device is sealedto the inner wall of the atrium so that a fluid-tight seal is formedbetween the outer wall of the one-way valve device and the inner wall ofthe left atrium. In this regard, the valve device can include a sealmember that is configured to seal to the inner wall of the atrium.

Another embodiment involves a prosthetic for treating heart disease ingeneral and defective or diseased mitral valves in particular. FIG. 21Ashows a prosthetic ring 800 that is sized to fit within a mitral valveannulus The ring 800 includes one or more anchors 805 that extend aroundthe periphery of the ring 800. In addition, one or more struts 810struts extend across the diameter of the ring, and can be made of amaterial that includes shape-memory metal (e.g. Nitinol) or magneticwires for selectively adjusting the shape of the ring. The struts canalso be instrumental in baffling mitral valve leaflet “flail”. FIG. 21Bshows another embodiment of a prosthetic ring 807 wherein a one-wayvalve 815 is positioned inside the ring such that blood flow BF can flowthrough the valve in only one direction. The valve can be manufacturedof various materials, such as silicone.

FIG. 22 shows a prosthetic with one or more tongues or flaps 910 thatare configured to be positioned adjacent the flaps of the mitral valve.The prosthetic includes a ring 900 sized to fit within a mitral valveannulus. At least two tongues 910 project from the ring 900 in a caudaldirection when the ring is implanted into a heart of an individual. Thering 900 is flexible between an expanded configuration and a contractedconfiguration and is biased toward the contracted configuration. One ormore anchors 920 protrude from the flexible ring 900 for coupling thering coaxially to the annulus such that the contracted configuration ofthe ring exerts an inward force to the annulus. Alternatively, or inaddition, the two tongues 910 can each have a length sufficient toprevent prolapse of a mitral valve when the ring is placed atop theleaflets of the mitral valve. In a further embodiment the tongueelements may be attached at a central point.

In yet another embodiment, a prosthetic for treating heart disease ingeneral and a defective or diseased mitral valve in particular includesa wedge 1205 used to support the leaflet and/or prevent prolapse orflail of the leaflet. The wedge 1205 may be implanted on either theventricular side of the leaflet. FIG. 24 depicts the wedge 1205 on theventricular side of the leaflet. According to one embodiment, the wedge1205 has a length that is up to a length of the line of coaptation of amitral valve. In an embodiment, the wedge 1205 has a length that is aslong as the leaflet segment needing support.

The wedge can have a depth sufficient to prevent prolapse of a mitralvalve when the wedge is placed atop an annulus of the mitral valve alongthe line of coaptation, and may provide a point of coaptation for eachleaflet. One or more anchors can protrude from the wedge for couplingthe wedge to the annulus of the mitral valve. Methods of treatment usingthe wedge are also disclosed. The methods include inserting the wedgeinto an individual's heart, placing the wedge lengthwise along the lineof coaptation of the mitral valve. The wedge is then secured to anannulus of the mitral valve along the LV wall. The wedge may bepositioned also just under one segment of the leaflet (likely P2 or P3in the case of functional MR).

In yet another embodiment, a device for treating heart disease includesa clip for attachment to a free end of a heart valve leaflet. FIG. 23Ashows an exemplary embodiment of one or more clips 1101 that arepositioned on free edges of the leaflets LF. Each of the clips 1101 hasa shape that prevents flail of the leaflet by catching against anunderside of an opposing leaflet. Methods of treatment using the clipare also disclosed. The methods include introducing the clip into anindividual's heart and attaching the clip to a free end of a heart valveleaflet opposite the free end of an opposing leaflet of the heart valveso that the clip catches to the underside of the opposing leaflet duringsystole. In a further embodiment, a clip may be placed on both leafletssuch that the clips meet or catch when the leaflets are in proximity.The clips may attach momentarily during systole, and then detach duringdiastole, or may clip permanently resulting in a double orifice mitralvalve anatomy. The clips of this embodiment may include a magneticelement, or one may be magnetic and the other of a metal materialattracted to said magnetic field of the magnetic clip.

In the case of magnetic clips, the clip elements may be placed on theunderside of the leaflets (e.g. not necessarily on the free edge of theleaflet), provided that the magnetic field of the clip is sufficient toattract the opposing magnetic or metal clip element. This is furtherdescribed with reference to FIG. 23B, which shows pair of leaflets LFwith a clip 1101 attached to the underside of each leaflet. At least oneof the clips is magnetic, while the other clip is of an oppositemagnetic polarity than the first clip or of a metal attracted to themagnetic field of the first clip. The magnetic field is sufficientlystrong such that the clips 1101 can attach to one another eithermomentarily or permanently to coapt the leaflets, as shown in FIG. 23C.

In another embodiment, shown in FIG. 23D, a single clip 1101 is attachedto one of the leaflets. The clip 1101 is sufficiently long to increasethe likelihood that the clip 1101 will coapt with the opposite leaflet.

In yet another embodiment, a device for treating heart disease includesa wedge for placement under a heart valve leaflet. FIG. 24 shows aschematic, cross-sectional view of the heart with a wedge 1205positioned below at least one of the leaflets of the mitral valve. Thewedge 1205 can be positioned below one or both of the leaflets. Thewedge 1205 is sized to fit under the valve leaflet and caudal theannulus of the heart valve. The wedge 1205 can have a shape that iscontoured so as to provide support to a lower surface of the leaflet.(In FIG. 24, the left atrium is labeled LA and the left ventricle islabeled LV.) An anchor is attached to the wedge for coupling the wedgeto a wall of the heart chamber adjacent the heart valve. The wedge formsa fixed backstop against the bottom side of the heart valve leaflet,thereby providing a location for the leaflet to coapt against, and/orproviding support or “pushing up” a restricted leaflet.

Other embodiments are directed to altering the size, shape, chemistry,stiffness, or other physical attributes of heart valve leaflets. In oneembodiment in particular, a method of treating heart disease includesobtaining access to a heart valve leaflet and injecting a stiffeningagent into the leaflet to stiffen the leaflet and minimize flail.

Other embodiments are directed to the chordae that connect heart valveleaflets to the inner walls of the heart. In one embodiment inparticular, a method of treating heart disease includes obtaining accessto a heart valve chord and cutting it mechanically or with energy suchas a laser, or by heating the chordae to elongate them, thereby allowingthe previously restricted leaflet to be less restricted so that it cancoapt with the opposing leaflet.

In another embodiment directed to the chordae that connect heart valveleaflets to the inner walls of the heart, a cam-shaped ring isdisclosed. The cam-shaped ring is sized to fit within a left ventricleof a heart. The ring forms a hole that is sized to receive two or morechordae tendineae. The ring is formed by connecting two detachable endsof the ring.

Methods of treatment using the cam-shaped ring are also disclosed. Onemethod in particular includes introducing the ring into a left ventricleof a heart. One or more chordae tendineae are then surrounded by thering, and the two ends of the ring are then attached to form a closedring around the chordae tendineae. The ring is then rotated such thatone or more of the chordae tendineae are shifted away from their initialorientation by the rotation of the cam-shaped ring. The ring may then befixed in the rotated or tightened position.

An embodiment directed at the chordae of heart valve leaflets is nowdescribed. FIG. 25A shows a device that can be used to alter a chordae.A method includes obtaining access to a chordae tendinea (chord) withinan individual's heart chamber. The chordae is then cut at a point alongits length so that a length of the chorda tendinea is freed from theheart chamber leaving behind a length of chorda tendinea having a freeend and an end attached to an edge of a heart valve.

With reference to FIG. 25A, a synthetic chord 1005 of greater lengththan the free length of chordae is introduced into the heart chamber.One end of the synthetic chordae 1005 is connected to a wall 1305 of theheart chamber or to a muscle attached to the wall of the heart chamber.Another end of the synthetic chord is attached to the free end of thechorda tendinea or to the leaflet.

In this regard, the end of the chord 1005 that is attached the wall 1305can have any of a variety of devices that facilitate such attachment.FIGS. 25B and 25C show enlarged views of attachment devices containedwithin box 13 of FIG. 25A. The attachment devices can be used to attachthe chord 1005 to the wall 1305. In FIG. 25B, the attachment device 1310is an enlarged ball having a distal trocar for penetrating the wall1305. In FIG. 25C, the attachment device 1310 is a hook that isconfigured to penetrate through the wall 1305. It should be appreciatedthat the attachment device 1310 can have other structures and it notlimited to the structures shown in FIGS. 25B and 13C. In variations ofthese embodiments, it may be advantageous to adjust the length of thechordae (synthetic, or modified), determine the therapeutic effect ofthe shortening or lengthening, and then fix the chordae at the mostefficacious location.

Other embodiments are directed to atrial or ventricular remodeling toalter the shape of an atrium or ventricle. FIG. 26 shows across-sectional view of the heart with a first and second anchorattached to a wall of the heart. The system includes a first anchor 1410a having a screw portion 1415 for screwing into a wall of the heart anda connector portion. The connector portion is rotatable around an axisof rotation. The first anchor includes a power source to power rotationof the connector portion and a receiver for receiving telemetric signalsfrom an external controller for controlling the rotation of theconnector portion. The system includes a second anchor 1410 b having ascrew portion 1415 b for screwing into a wall of the heart and aconnector portion. Also included is a tether 1420 having two free ends.One of the free ends is coupled to the connector portion of the firstanchor, and the other free end is coupled to the connector portion ofthe second anchor. An external controller is also included. The externalcontroller has a telemetric transmitter for communicating with thereceiver and controls the rotation of the connector portion.Alternatively, the anchors may be placed with a torqueable catheter.

In another embodiment, a method of altering a geometry of a heartincludes introducing a first coupler into a heart chamber. The firstcoupler has an anchor portion and a connector portion. The connectorportion is rotatable around an axis of rotation and is connected to apower source to power rotation of the connector portion. The powersource is in communication with a telemetric signal receiver. The firstcoupler is secured to the wall of the heart chamber by anchoring theanchor portion to the wall. A second coupler is introduced into theheart chamber. The second coupler includes an anchor portion and aconnector portion. The second coupler is secured to the wall of theheart chamber by anchoring the anchor portion to the wall at a distancefrom the first coupler.

A tensile member is introduced into the heart chamber. One end of thetensile member is connected to the connector portion of the firstcoupler, and another end of the tensile member is connected to theconnector portion of the second coupler. The distance between the firstand second couplers is adjusted by transmitting a telemetric signal tothe receiver, thus causing the connector portion to rotate around theaxis of rotation and threading the tensile member around the connectorportion to reduce the distance between the first and second couplers.

In another embodiment, a system for altering the geometry of a heartchamber includes a planar tensile member having substantially inelasticmaterial. At least two anchors are included for anchoring the planartensile member to an inner wall of a heart chamber. The planar tensilemember is substantially shorter in length than a left ventricle of aheart so that when the planar tensile member is anchored in a caudaldirection along a length of the left ventricle a tensile force exertedby the planar tensile member between the two anchors prevents the leftventricle from dilating caudally.

In another embodiment, a method for altering the geometry of a heartincludes providing a tensile member having a substantially inelasticmaterial. The tensile member is substantially shorter in length than aleft ventricle of a heart. The tensile member is inserted into the leftventricle of the heart and a proximal end of the tensile member isanchored to the left ventricle adjacent the mitral valve. A distal endof the tensile member is anchored to the left ventricle caudal theproximal end so that a tensile force exerted by the tensile memberbetween the two anchors prevents the left ventricle from dilatingcaudally.

Other embodiments are directed to strengthening or reshaping the leftventricle of the heart. In one embodiment in particular, a method ofreinforcing the left ventricle includes injecting a strengthening agentinto a wall of the left ventricle in an enlarged region of theventricle, as shown in FIG. 27. FIG. 27 shows a catheter 1510 that hasbeen introduced into the heart. The catheter 1510 has an internal lumenthrough which the strengthening agent 1512 can be injected. A proximalend of the catheter is connected to a source of the strengthening agentand a distal end of the catheter is configured to release thestrengthening agent. As shown in FIG. 27, the distal end of the catheteris positioned at or near a wall of the heart and the strengthening agent1512 is injected into the wall of the heart.

In another embodiment, a method is directed to altering the geometry ofa heart. The method includes injecting a polymerizing agent into apericardial space adjacent a left ventricle, thereby exerting a medial(inward) force against the left ventricle.

In yet another embodiment, a method of altering the geometry of a heartincludes inserting a balloon into a pericardial space adjacent to a leftventricle of the heart, or extend into the pericardium of the heart. Theballoon is inflated by injecting it with a fluid, and it exerts a medialforce against the left ventricle upon inflation. In certain embodiments,the balloon can be inflated at the time of implantation, or at a latertime. If inflated at a later time, the balloon would be self-sealing,and may be inflated by accessing the balloon with a needle placedthrough the chest wall.

Other embodiments are directed to adjusting the length or orientation ofpapillary muscles. FIG. 28 shows a schematic view of the heart showingthe papillary muscles PM. With reference to FIG. 28, a method oftreating heart disease includes inserting an anchor, cuff or sleeve 1205into the left ventricle of an individual's heart, and sliding a cuff orsleeve around a papillary muscle PM. The size of the cuff or sleeve isreduced so that the cuff or sleeve squeezes the papillary muscle. As thesize of the cuff or sleeve is reduced, the papillary muscle stretchesand increased in length.

In yet another embodiment, a method of treating heart disease includesobtaining access to a papillary muscle in a left ventricle of the heart.The papillary muscle is cut and reattached at a new location on an innerwall of the ventricle closer to the mitral valve.

Additional embodiments that employ magnets in the heart are nowdescribed with reference to FIGS. 29-31, which show cross-sectionalviews of the heart. With reference to FIG. 29, in one embodiment one ormore magnets 1705 are implanted or otherwise attached to a wall 1710 ofthe left ventricle LV. One or more other magnets 1715 are implanted orotherwise attached to a wall 1720 of the right ventricle. The magnets1705 and 1715 are attached to the walls 1710 and 1720 such that theyassert an attractive magnetic force (as represented by the arrows 1725in FIG. 29) toward each other. The magnetic force 1725 assists inremodeling of the left ventricle during pumping of the heart. That is,the magnets 1705 and 1715 are urged toward one another (thereby alsourging the walls 1710 and 1720 toward one another) to re-shape eitherthe annulus AN or the left ventricle LV. The annulus or the leftventricle LV are re-shaped in a manner that reduces or eliminatesbackflow through the mitral valve MV. It should be appreciated that asimilar procedure can be performed on the right ventricle RV andassociated valves.

FIG. 30A shows another embodiment of a procedure wherein magnets areimplanted in the heart to geometrically reshape the annulus or the leftventricle. One or more magnets 1705 are implanted or otherwise attachedto a first wall 1710 a of the left ventricle LV. One or more magnets1705 are also implanted or otherwise attached to a second, opposed wall1710 b of the left ventricle. The magnets on the opposed walls 1710 a,1710 b exert an attractive magnetic force toward one another to draw thewalls 1710 a, 1710 b toward one another and re-shape the left ventricleLV or the annulus AN.

Another embodiment of a procedure uses magnets to anchor tethers withinthe heart at various locations to optimize the shape of cardiacstructures to improve cardiac function. The tethers are placed to eitherreshape the cardiac structure or to prevent dilatation of the structureover time. The tethers must be securely anchored to the heartstructures. A method of anchoring which enables tethering in variouspositions and directions within the cardiac structures is important forthe clinician to optimize cardiac reshaping based on each individualpatient anatomy and disease state. A method of anchoring which isatraumatic is also desirable.

FIG. 30B shows a side view of the heart with sets of magnets A, A1, B,and B1 positioned to various locations of the heart or to anatomicalstructures adjacent the heart. In one embodiment, at least one magnet Ais placed on the interventricular septum within the right ventricle RV.At least one magnet A1 is placed within the left ventricle LV oppositemagnet A. The magnetic force between A and A1 maintains the position ofthe magnets. The magnets may be enclosed in materials that will promotetissue in-growth and healing to the interventricular septum to ensurestability of location and to eliminate the need for long termanti-coagulation. Additionally, the enclosure material which is flexibleand can be delivered in a low profile can be significantly larger insize than the magnets to increase the surface area of contact with theheart wall which will increase the tension that can ultimately be placedon the anchor over time.

A second set of magnets B and B1 are then delivered to another locationselected within or adjacent to the heart. The set of magnets A/A1 areattached to the set of magnets B/B1 using at least one tether 1805, asshown in FIG. 30B. The tether 1805 can be attached to either or both ofthe magnets A/A1 at one end and to either of both of the magnets B/B1 atan opposite end. When the set of magnets B/B1 are tethered under tensionto the set of magnets A/A1, a change in the shape of the cardiacstructure results to improve cardiac function. FIG. 30B shows magnet Bpositioned in the LV and B1 positioned in a blood vessel BV adjacent tothe heart. The magnetic force between B and B1 maintains the location ofB and B1. Magnets B and B1 are delivered on or within materials andstructures which promote healing and increase the amount of tension thatcan be placed on the anchor over time. For example, magnet B1 can bedelivered on a stent which is of a length, diameter and material whichwill heal within the BV to provide sufficient resistance to forcesplaced on it by the tethers.

The tethers may be pre-attached to the magnets A and B1 or they may beattached after A and B1 have been positioned. The tether length may beshortened and/or adjusted after placement of the anchors. Alternativelythe final tether length may be pre-selected based on the patient'scardiac structure geometry and the effect the clinician desires. Placingsets of magnets in this method, enables anchoring of tethers within theheart in various positions and angles which provides increasedflexibility and variation for clinicians to select optimal re-shaping ofthe cardiac structures based on specific patient characteristics.

Examples which demonstrate the flexibility of this approach includeplacing anchors at the annulus and at the apex of the heart and tetheredto shorten the length of the LV; anchors can be placed in the around theannulus and tethered to change the shape of the annulus. Morespecifically, one or more sets of magnets can be placed in the RA and LAat the level of the mitral valve annulus (on the anterior side of theannulus) and one or more sets of magnets can be placed in the LA and LVon opposite sides of the annulus on the posterior portion of theannulus. The posterior sets of magnets can then be tethered to theanterior sets of magnets to change the shape of the annulus.Alternatively, the magnet anchors can be placed at the level of theannulus in the LA and in a BV adjacent to the heart at the level of theannulus and these then tethered to the anterior annulus magnet anchordescribed above.

The magnets A and A1 can also be a single magnet that extends throughthe interventricular septum. Moreover, only one of the magnets A or A1need be implanted. One or more magnets B and/or B2 are located oppositethe location of the magnet(s) A and/or A1. The magnet(s) B is locatedwithin the left ventricle opposite the magnets A/A1, such as on the leftventricular wall. The magnet B1 is located on an anatomical structureadjacent the heart, such as on a blood vessel BV.

In another embodiment shown in FIG. 30C, the magnets A, A1, B, and B1,or combinations thereof, are implanted in the heart without tethers. Themagnets A, A1, B, and B1 can be positioned in various combinations so asto exert magnetic attractions to one another to re-shape the leftventricle or the mitral valve annulus. For example, the magnets A and Bcan be implanted such that they exert an attractive magnetic forcerelative to one another. The magnets A and B2 can alternately beimplanted. Other possible combinations are the magnets A1 and B or themagnets A1 and B2. The magnets can be implanted without tethers suchthat an attractive magnetic force F causes the magnets and the attachedregion of the heart to move toward one another to re-shape the heart.Alternately, the magnets can be attached to one another with tethers.

In yet another embodiment, one or more magnets 1705 are implanted in thewalls 1710 of the left ventricle LV and/or the right ventricle RV, asshown in FIG. 31. The magnets 1705 are positioned in opposed locationson the walls 1710 and one or more tethers 1905 attach opposed pairs ofmagnets 1705 to one another. One or more of the tethers 1905 extendthrough the interventricular septum to connect a first magnet disposedin the left ventricle and a second magnet disposed in the rightventricle. In certain embodiments, magnet elements do not includetethers, but rely on the magnetic attraction to each other to remodelthe tissue between them. For example, a magnetic element may be placedon either side of the interventricular septum, or one element within theseptum. Another magnetic element may be placed on or within the oppositeleft ventricular wall, or in an adjacent vessel on the left ventricularwall. The electromagnetic field of such elements can then interact tocause a remodeling of the left ventricle to assist with ventricularfunction.

The tethers 1905 can be elastic so to exert an attractive force betweenthe attached magnets 1705 and re-shape the left ventricle LV or annulusAN. Alternately, or in combination with elastic tethers, the tethers1905 can be shortened in length after placement to thereby pull thewalls of the left ventricle LV toward one another and re-shape the leftventricle LV or the annulus AN. In combination with the force providedby the tethers 1905, the magnets 1705 exert an attractive magnetic forcetoward one another to assist in pulling the heart walls toward eachother.

It should be appreciated that one or more magnets can be positioned inother locations of the heart or adjacent anatomical structures forre-shaping of the heart. For example, one or more magnets can bepositioned around the annulus AN or can be positioned in the coronarysinus in such a manner that the magnets exert attractive forces towardone another to cause re-shaping of a desired portion of the heart.

In another embodiment, cardiac re-shaping is achieved throughpercutaneous placement of one or more tethers that are cinched oranchored in the walls of the left ventricle LV. The tethers providetension between the walls of the left ventricle to reshape the leftventricle LV in a desired manner. FIG. 32 shows a cross-sectional viewof the left ventricle LV with a tether 2010 positioned therein. Thetether 2010 has a first end anchored to a first wall of the leftventricle LV and a second end anchored to an opposed wall of the leftventricle LV. The tether 2010 is tensioned to pull the walls toward oneanother (as represented by the phantom lines 2012 in FIG. 32) andre-shape the left ventricle LV. It should be appreciated that thephantom lines 2012 in FIG. 32 are merely representative of the geometricre-shaping. The left ventricle LV can be re-shaped in various mannersand the amount of re-shaping can vary depending on the tension appliedto the tether 2010 and the location of attachment to the walls of theleft ventricle LV. The tether may be inelastic or somewhat elastic.

The tether 2010 can be anchored or otherwise attached to the walls invarious manners. In an exemplary embodiment, a patch 2015 (shown in FIG.32) of material is positioned on an exterior surface of the ventricularwall and is attached to one end of the tether 2010. A similar patch canalso be positioned on the opposed wall and attached to the opposite endof the tether.

With reference to FIG. 33, the patch is delivered to a desired locationusing a catheter 2105 having a sharpened distal end 2110 that ispositioned within the left ventricle LV. The catheter 2105 can bedelivered to the left ventricle LV in various manners, includingtrans-aortically (via the aorta), trans-septally (by piercing theinterventricular septum), and trans-atrially (via the left atrium LA)pursuant to well-known methods. As shown in FIG. 34, the sharpeneddistal end 2110 pierces the ventricular wall such that the distal end2110 is positioned exterior to the ventricular wall. The catheter 2105has an internal delivery lumen having an opening at the distal end 2110.The patch 2015 is configured to be transported in a contracted statethrough the delivery lumen and delivered out of the opening at thedistal end 2110, where the patch 2015 expands into an expanded state atthe exterior of the ventricular wall to seal against the exterior of theleft ventricular wall.

When positioned at the exterior of the ventricular wall, the patch 2015is configured to act as a reservoir that receives a fluid material thatcan be delivered to the patch via the delivery lumen of the catheter2105. The fluid material has a first viscous state of sufficientfluidity such that the material can flow through the delivery lumen ofthe catheter 2105 and out of the distal end 2110 to the location of thepatch 2015. The fluid material changes to a second viscous state whenpositioned exterior to the ventricular wall at the patch 2015. Thesecond viscous state is of greater viscosity (i.e., more resistant toflow) than the first viscous state such that the fluid material providessupport and a level of rigidity to the patch 2015 and to the leftventricular wall. The fluid material can change to the second viscousstate after a predetermined time period, after contact with the patch,or when the patch is completely filled. A catalyst can be injected intothe fluid material to cause it to change to the second viscous state.

As shown in FIG. 35, the catheter 2105 can then be disengaged from thepatch 2015 such that the patch 2015 is disposed exterior to theventricular wall. The patch 2015 can be firmly attached to theventricular wall (such as using an adhesive) to minimize wear orfriction between the patch and the ventricular wall. Next, an end of thetether 2010 is attached to the patch 2015. The catheter 2105 can be usedto deliver the tether 2010 to the patch 2015 or, alternately, a secondcatheter can be used. In one embodiment, the tether 2010 is alreadypositioned in a delivery lumen of the catheter 2105 while the patch 2015is being delivered. The catheter 2105 is then pulled back while the endof the tether 2010 remains attached to the patch 2015 to thereby let thetether 2010 out from the catheter 2105, as shown in FIG. 35.

With reference now to FIG. 36, a second patch 2415 is deployed in orexterior to an opposed ventricular wall in a manner similar to thatdescribed above. The opposite end of the tether 2010 is then attached tothe second patch 2415 such that the tether 2010 extends between the twopatches, as shown in FIG. 32. Alternately, as shown in FIG. 36, a secondtether 2420 is attached at a first end to the second patch 2415. Asshown in FIG. 37, the two tethers 2010 and 2420 can then be attachedtogether at opposite ends from the patches, such as by using a clip2510, to form a single attachment tether between the patches 2015 and2415. The tethers 2010 and 2420 can be twisted or adjusted within theclip 2510 to tension the resulting attachment tether between the patches2415 and 2015 and pull the ventricular walls toward one another via thetether. Once properly tensioned, the tether can be clipped or clamped tomaintain its position.

In another embodiment, shown in FIG. 38, a needle 2610 or deliverycatheter is passed trans-thoracically into the left ventricle LV todeliver a patch 2615 to the exterior of the ventricular wall, asdescribed above. A sealing means, such as a sealing balloon, can be usedto seal one or more puncture holes in the wall of the left ventriclecaused by the needle 2610 during delivery of the patch 2615.Visualization means, such as fluoroscopy, can be used to visualizeproper placement of the needle 2610. A second patch is attached to anopposed wall to form a tether attachment between the walls, as shown inFIG. 32. The tether is then tensioned to pull the walls together andre-shape the left ventricle or annulus of the mitral valve in a desiredmanner.

In other embodiments, described with reference to FIGS. 39-43, cardiacre-shaping is achieved by manipulation of the papillary muscles. FIG. 39shows a schematic, cross-sectional view of the left ventricle LV in ahealthy state with the mitral valve closed. The valve chordae CH connectthe leaflets LF of the mitral valve to the papillary muscles PM. Thepapillary muscles PM and the and chordae CH are positioned such that atleast a portion of the leaflets LF contact one another when the mitralvalve is in the closed state, resulting in functional coaptation of theleaflets.

FIG. 40 shows the left ventricle LV in a dysfunctional state. The valvechordae CH or the papillary muscles PM are damaged or otherwisedysfunctional such that the leaflets LF do not properly coapt (contactone another). The dysfunction can be manifested by excess tension in thechordae CH such that a gap is located between the leaflets LF, or insome cases one leaflet may function at a different level from the other(e.g. lower (prolapse) or higher (flail)) thereby limiting the abilityof the mitral valve to close resulting in mitral regurgitation. Thedysfunctional left ventricle LV and in some cases leaflet prolapse orflail, can be treated by manipulating papillary muscles PM to adjust theposition of the leaflets LF. In one embodiment, the papillary muscles PMare repositioned toward one another to reduce the distance between thepapillary muscles PM.

In an embodiment described with reference to FIG. 41, a biasing member,such as a rod of adjustable length, or a spring 2910, is mounted betweenthe papillary muscles PM with a first end of the spring 2910 attached toa first papillary muscle and a second end of the spring 2910 attached toa second papillary muscle. The spring 2910 has a pre-load such that thespring 2910 provides a biasing force (represented by the arrows 2915 inFIG. 41) that pulls the papillary muscles PM toward one another. Such aspring may be covered with polyester fabric or other coating to promoteingrowth into the muscle tissue and minimize the potential for clotformation. The repositioning of the papillary muscles PM re-shapes theleft ventricle and/or changes the distance that the leaflets need tomove on the chordae CH such that the leaflets LF contact one another toclose the mitral valve. The tension provided by the spring 2910 can bevaried or different springs can be used to achieve a properrepositioning of the papillary muscles PM. The tension may be modifiedat the time of the procedure or during a subsequent procedure if it isdetermined that additional coaptation is required.

In another embodiment, described with reference to FIG. 42, a suture3010 is mounted between the papillary muscles PM with a first end of thesuture 3010 attached to a first papillary muscle and a second end of thesuture 3010 attached to a second papillary muscle. The suture 3010 canbe attached to the papillary muscles in various manners. For example, anattachment device 3015, such as an anchor, cuff or sleeve, can bepositioned around or partially around each of the papillary muscles. Theends of the suture 3010 are attached to the attachment devices 3015 tosecure the suture 3010 to the suture to the papillary muscles.

The suture 3010 is tensioned such that it provides a force that pullsthe papillary muscles PM toward one another. The suture 3010 can betensioned, for example, by twisting the suture 3010 to reduce its theoverall length and thereby reduce the distance between the papillarymuscles PM, and fixing the suture with a crimping element or other stayelement. The amount of twisting or shortening can be varied to vary thetension provided by the suture 3010. In addition, a crimping member maybe used to fix the sutures once a desired tension between the muscles isreached. Exemplary crimping members are described in InternationalPatent Application Number PCT/US03/06149, which is incorporated hereinby reference in its entirety. As in the previous embodiment, therepositioning of the papillary muscles PM re-shapes the left ventricleand/or changes the tension on the chordae CH such that the leaflets LFcontact one another to close the mitral valve. Cuffs or sleeves may beplaced around the papillary muscles PM to such as those previouslydescribed, to affect the repositioning.

With reference now to FIG. 43, the papillary muscles PM can also berepositioned by snaring the papillary muscles. A snare 3110 comprised ofa looped strand of material is positioned around the chordae CH at ornear the location where the chordae attach with the papillary musclesPM. The snare 3110 is tightened to draw the papillary muscles PM towardone another and re-shape the left ventricle and/or changes the distancethat the leaflets need to travel during systole such that the leafletsLF contact one another to close the mitral valve.

In yet another embodiment, shown in FIG. 48, one or more clips 3610 areclipped to each of the papillary muscles PM. The structure of the clips3610 can vary. A tether 3615 attaches the clips 3610 to one another. Thetether 3615 is cinched to shorten the length of the tether 3615 and pullthe papillary muscles PM toward one another and re-shape the leftventricle and/or changes the distance that the leaflets need to travelduring systole such that the leaflets LF contact one another to closethe mitral valve.

In yet another embodiment, shown in FIG. 49, one or more clips 3610 areclipped to opposed walls of the left ventricle LV. The clips 3610 can bedelivered to the left ventricle using a delivery catheter 2105. A tetherattaches the clips to one another. The tether is cinched to shorten thelength of the tether and pull the ventricular walls toward one anotherand re-shape the left ventricle and/or changes the distance that theleaflets need to travel during systole such that the leaflets LF contactone another to close the mitral valve.

In all embodiments, once the papillary muscles are fixed orrepositioned, it may be advantageous to further treat the area byselectively elongating or shortening the chordae tendinae to achievefurther optimal valve function. In addition, a mitral valve clip may bedeployed to augment the desired valve function, either before papillaryor chordal manipulation, or after, if the desired leaflet coaptation isnot achieved with one particular approach.

As discussed above with reference to FIG. 40, a dysfunctional leftventricle can be manifested by excess tension in the chordae CH suchthat a gap is positioned between the valve leaflets LF. It can bedesirable to eliminate or relieve the excess tension by cutting thechordae CH, and/or cutting the chordae and replacing them withartificial chordae. Prior to cutting the chordae, it can be desirable toevaluate the placement of the artificial chordae to confirm thatimplantation of the chordae will indeed provide the desired clinicalresult. This process is now described with reference to FIGS. 44-47.

FIG. 44 shows a leaflet grasping device 1100 that is configured to graspand secure the leaflets of the mitral valve. The device 1100 andcorresponding methods of use are described in more detail in U.S. PatentApplication Publication No. 2004-0030382, entitled “Methods andApparatus For Cardiac Valve Repair”, which is incorporated herein byreference in its entirety. Additional leaflet grasping devices aredescribed in U.S. Patent Application Publication No. 2004-0092962, filedMay 19, 2003, U.S. Pat. No. 6,269,819, issued Aug. 7, 2001, and U.S.Pat. No. 6,461,366, issued Oct. 8, 2002, all of which are expresslyincorporated by reference herein.

Referring to FIG. 44, the device 1100 is comprised of a catheter shaft1102 having a distal end 1104 and a proximal end 1106. The cathetershaft 1102 is comprised of, among others, a conduit 1108, a coaxialouter sheath 1110, a central lumen 1111 through which a double-jawgrasper 1113 may be inserted, and a central guidewire lumen 1105. Thecatheter shaft 1102 can have additional lumens for the passage of one ormore needles, as described more fully below.

Toward the distal end 1104, an optional pair of stabilizers 1112 arefixedly mounted on the outer sheath 1110 at their proximal end 1114 andfixedly attached to extenders 1116 at their distal end 1118. Thestabilizers 1112 are shown in an outwardly bowed position, however theymay be inwardly collapsed by either extending the extenders 1116 orretracting the outer sheath 1110. Bowing may be achieved by the reverseprocess.

The double-jaw grasper 1113 is comprised of two articulating jaw arms1120 which may be opened and closed against the central shaft 1122(movement depicted by arrows) either independently or in tandem. Thegrasper 1113 is shown in the open position in FIG. 44. The surfaces ofthe jaw arms 1120 and central shaft 1122 may be toothed, as shown, ormay have differing surface textures for varying degrees of friction. Thejaw arms 1120 each include a needle passageway 1121 comprised of acutout or a slot that extends at least partially along the length ofeach jaw arm 1120. As described in more detail below, the needlepassageway provides a location where a needle can pass through the jawarm 1120 during manipulation of the papillary muscle.

The above described components may be manipulated and controlled by ahandle 1126 connected to the proximal end 1106 of the catheter shaft1102, as shown in FIG. 44. the handle 1026 permits independent controlof the components described above.

Referring to FIGS. 45A-C, the device 1100 may be used at leasttemporarily grasp and restrain the valve leaflets LF of the mitral valveMV. The double-jaw grasper 1113 extends through the valve such that theleaflets LF1, LF2 are grasped from below. Thus, the device 1100 istermed “atrial-ventricular.”

Referring to FIG. 45A, the atrial device 1100 may be stabilized againstthe mitral valve MV. The stabilizers 1112 may be positioned on thesuperior surface of the valve leaflets LF1, LF2 at a 90 degree angle tothe line of coaptation. The grasper 1113 may be advanced in its closedposition from the conduit 1108 between the leaflets LF1, LF2 until thejaw arms 1120 are fully below the leaflets in the ventricle. At thispoint, the grasper 1113 may be opened and retracted so that the jaw arms1120 engage the inferior surface of the leaflets LF1, LF2. In thismanner, the leaflets are secured between the stabilizers 1112 and thejaw arms 1120.

Referring to FIG. 45B, the grasper 1113 will gradually close, drawingthe leaflets LF1, LF2 together while maintaining a secure hold on theleaflets between the jaw arms 1120 and the stabilizers 1112. This may beaccomplished by number of methods. For example, the stabilizers 1112 maybe gradually collapsed by either extending the extenders 1116 orretracting the outer sheath 1110. As the stabilizers 1112 collapse, thejaw arms 1120 may collapse due to spring loading to gradually close thegrasper 1113. Alternatively, the jaw arms 1120 may be actuated to closeagainst the central shaft 1122 applying force to the stabilizers 1112causing them to collapse. In either case, such action allows thestabilizers 1112 to simultaneously vertically retract and withdraw fromthe leaflets as the leaflets are clamped between the jaw arms 1120 andthe central shaft 1122. In this manner, the leaflets are effectively“transferred” to the grasper 1113. Referring to FIG. 45C, once thecollapsed stabilizers 1112 are completely withdrawn, the leaflets LF1,LF2 are held in vertical opposition by the grasper 1113 in a morenatural coaptation geometry.

With reference now to FIG. 46, a needle 3410 is advanced from the leftatrium into the left ventricle. The needle 3410 can be passed through alumen in the device 1100 or it can be passed external to the device1100. In any event, the needle 3410 passes through a leaflet LF and intoa papillary muscle PM. As mentioned, the jaw arms 1120 have needlepassageways 1121 (shown in FIG. 44) that permit passage of the needlethrough the jaw arms 1120.

The needle 3410 is attached to a suture 3415 that extends distallythrough the device 1100. The suture 3415 is then anchored to thepapillary muscle PM such that the suture 3415 provides an attachment forholding, pulling, or otherwise manipulating the papillary muscle PM. Thetension in the suture 3415 can be adjusted to re-position the papillarymuscle PM such that the leaflets LF contact one another to close themitral valve. The same process can be performed with the other papillarymuscle.

With the sutures 3415 holding the papillary muscles PM in a desiredposition, as shown in FIG. 47, the chordae CH may be cut. The sutures3415 function as artificial chordae that retain the leaflets LF andpapillary muscles PM in a desired orientation.

A fixation device such as a clip can then be attached to the leafletsusing methods and device described in U.S. Patent ApplicationPublication No. 20040030382, filed Aug. 5, 2003, U.S. Patent ApplicationPublication No. 20040092962, filed May 19, 2003, U.S. Pat. No.6,269,819, issued Aug. 7, 2001, and U.S. Pat. No. 6,461,366, issued Oct.8, 2002, all of which are expressly incorporated by reference herein.The sutures 3415 can be attached to the clip 3510 or directly to theleaflets LF. It should be appreciated that any quantity of sutures 3415can be used as artificial chordae between the leaflets and the papillarymuscles. It should be appreciated that the leaflet clips can also beused in conjunction with cutting, elongating, or shortening of thechordae pursuant to the methods described above.

Prior to permanently placing the chordae or clips, the result can bepreviewed on ultrasound (TEE, ICE, echocardiography), to determine ifthe appropriate valve coaptation is restored. In addition, it is withinthe scope of the present invention to implant a mitral valve clip inaddition to performed papillary muscle approximation or chordalimplantation.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theappended claims should not be limited to the description of theembodiments contained herein.

What is claimed is:
 1. A method for treating regurgitation through avalve in a heart, the heart having an atrium fluidically coupled to aventricle by the valve, the valve including at least two leaflets whichcoapt along a line of coaptation, the method comprising: introducingpercutaneously a medical device system into a patient's heart to avicinity of a gap within the line of coaptation of the valve, themedical device system comprising: a steerable guide catheter configuredfor delivery through the patient's vasculature to the vicinity of thegap; a retractable sheath moveably disposed over a device comprising aframe sized to fit within a heart chamber and a pair of arms moveablycoupled to the frame, the arms are structurally configured to move froma fluid flow-blocking position during a systole to a fluid flow-allowingposition during a diastole in response to pressure changes occurringbetween the systole and the dystole; using the guide catheter toposition the device within the gap along the line of coaptation;retracting the sheath to release the blocker from compressive forcesmaintaining the device in the delivery configuration; expanding thedevice after positioning the device along the line of coaptation; andretracting the catheter and the sheath from the heart.
 2. The method ofclaim 1, wherein the frame further comprises a stationary portioncoupled to a proximal portion of the pair of arms, wherein thestationary portion is positioned above the level of the annulus andwherein the stationary portion has a long caxis oriented orthogonal tothe line of coaptation.
 3. The method of claim 1, wherein the pair ofarms are coupled to the frame by a hinge.
 4. The device of claim 1,wherein the tether connects to the frame at a lower surface of thestationary portion.
 5. The device of claim 2, wherein the long axis ofthe stationary portion has a length sufficient to contact an anteriorand posterior annulus.
 6. The device of claim 1, wherein the device canbe repositioned in the heart, redeployed in the heart and removed fromthe heart.